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Voluntary Product Recall Notification Codman® Certas™ Programmable Shunt May 31, 2013

Posted by mvarlan in Uncategorized.
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You may have heard that Codman, the neurological division within the Johnson & Johnson Company, has initiated a voluntary recall for one of its shunt products. We have passing on important information from the quality regulatory Director at Johnson & Johnson; which is posted on  the Hydrocephalus Association website.

There is no reason for patients who have this devise already implanted to have it replaced. Keep in mind this is a voluntary recall and not required by the FDA.

For details about this recall please read the information below.

Regards,
Maggie Bobrowitz, RN, MBA

 

Behind the Recall: Codman Provides Details

On Friday, May 17, 2013, HA provided information regarding the proactive decision on the part of Codman to recall any CODMAN® CERTAS™ Programmable Valves in stock at hospitals and medical facilities. As a follow up to the initial announcement, HA spoke with members of our Medical Advisory Board (MAB) and with a vice president from Codman Neuro about how the recent recall of CODMAN® CERTAS™ Programmable Valves, also known as shunts, relates to patients.

“The key factor in my mind, from the minute I received contact from Codman was the word ‘recall,’ which is a word loaded with meaning and, to most people, usually means something bad or dangerous,” stated Michael A. Williams, M.D., Medical Director of The Sandra and Malcolm Berman Brain & Spine Institute at Sinai Hospital of Baltimore, Maryland and member of the MAB. “…I knew the recall was not for a dangerous reason and there was nothing dangerous to our patients and families.”

“There is no reason, based on the details of the recall, for patients who currently have the CODMAN CERTAS Valve to have it removed,” added MAB Chair Marion “Jack” Walker, M.D., professor of Neurological Surgery at the University of Utah Health Sciences Center, Primary Children’s Medical Center, Salt Lake City, Utah. “As with most programmable valves, patients should ask to have their shunt settings verified after an MRI, particularly if they had the MRI outside of their normal medical facility.”

Behind the Recall: Codman Provides Details

In order to learn more about Codman’s thought process around the recall, HA sat down with Tom Megerian, M.D., Ph.D., who serves as Vice President of Strategic Medical Affairs and Medical Sciences for Codman Neuro. He is also a practicing neurologist.

HA: Why did Codman Neuro choose to voluntarily recall the CODMAN CERTAS Programmable Valve?

DR. MEGERIAN: First, it’s important to recognize that the recall was not initiated as a result of reported problems or adverse patient events, and this should not have a significant impact on how patients’ hydrocephalus is managed.

There are two factors that led to the recall. We found that the magnetic resonance imaging (MRI) resistance and the programming mechanism may not always operate properly in a small percentage* of CODMAN CERTAS Valves. (*According to Codman, based upon reported data.)

HA: Can you explain these two factors in more detail?

DR. MEGERIAN: I’m glad you asked, because this is a complex situation, and we want patients and the broader hydrocephalus community to fully understand so that we don’t cause unnecessary concern or alarm.

As with most programmable shunts, an unintended change in the valve setting may occur following an MRI procedure. This is a common issue that neurosurgeons and neurologists are accustomed to taking into account when utilizing programmable valves in general. To help address this issue, we designed the CODMAN CERTAS Valve to be MRI resistant. However, there’s a slight chance that some individual valves may not always be fully MRI resistant. We’ve always recommended that patients have their CODMAN CERTAS Valve setting verified following exposure to an MRI, and we’re now urging both physicians and patients to follow this important recommendation.

Additionally, one of the benefits of a programmable valve is that its pressure setting can be adjusted to meet individual patient needs over the course of time. In the rare case that a programming difficulty occurs, which would only happen when a patient’s valve is being adjusted during a medical appointment, there are steps that clinicians can take that may resolve this issue.

HA: Is the programming issue you described related to changing the valve settings or with checking/reading the settings?

DR. MEGERIAN: In rare cases, difficulty may occur when a physician initially programs or changes the valve settings. In most cases, this is resolved by the physician performing additional programming steps. The programming issue identified in the recall is not related to checking or reading the setting.

HA: Does this affect the valve’s “off” setting?

DR. MEGERIAN: The recall is not related to specific settings of the valve. I believe you’re referring to the fact that the CODMAN CERTAS Valve has a “virtual off” setting, which is setting eight. We often hear from clinicians who utilize the CODMAN CERTAS Valve that they appreciate having the option of the eighth setting, which is a very high setting comparable to a “virtual off” switch.

HA: How does the recall impact the patients who currently have the valve?

DR. MEGERIAN: For the most part, this shouldn’t impact patients who have the valve and are following the recommended step to have their valve setting verified after an MRI procedure.

HA: What recommendations do you have for patients? For clinicians?

DR. MEGERIAN: First, patients are advised to know what type of valve they have and its current setting, and to carry this information at all times. We provide cards with shunt information that patients can keep in their wallets. Second, patients who have the CODMAN CERTAS Valve should follow the recommendation to have their shunt setting verified following an MRI procedure. We are encouraging physicians to remind their patients of this as well. In cases where clinicians may have difficulty programming the valve, this can likely be overcome by additional efforts to reprogram the valve. Clinicians in need of further assistance can also contact their Codman Neuro representative for additional help with reprogramming.

As part of the recall, Codman Neuro is instructing clinicians and hospitals to identify and return CODMAN CERTAS Valves that may be in their inventories.

HA: What are the plans for the CODMAN CERTAS Valve going forward?

DR. MEGERIAN: We remain committed to the product and continue to believe in the benefits it can provide to patients. We’re working aggressively to resolve these issues and to return the product to market as soon as possible so that we can continue to help doctors in treating more patients who are suffering from hydrocephalus. In the meantime, clinicians can continue to use our other shunts, such as the CODMAN® HAKIM® Programmable Valve,** or the CODMAN® Precision Fixed Pressure Valve, which are not affected by the recall. (**HAKIM is a registered trademark of HAKIM LLC, USA and is used under license.)

HA: When will these issues be resolved and the product returned to the market?

It’s too early in our process to provide an estimated timeframe, however we are working to return the product to market as soon as possible.

HA: What steps has Codman Neuro taken as part of the recall process?

DR. MEGERIAN: We take any product recall very seriously, and there’s a process that we follow to notify our stakeholders in a responsible manner. This includes informing regulatory authorities, surgeons and hospitals in countries where the CODMAN CERTAS Valve is sold. Our immediate concern is getting in touch with clinicians who have used the valve so that they could be prepared to communicate with and to help manage their patients.

In addition to working with groups such as the Hydrocephalus Association to get the word out, we’ve provided physicians with information that can be sent to their patients. We’re working very closely with physicians and hospitals to manage the recall process.

HA: Is there any other message you want to express to the hydrocephalus community?

DR. MEGERIAN: We sincerely regret the need to undertake this recall, and we apologize for any potential concerns and the lack of product availability this may cause. As an organization, we are focused on continuing to advance the care of patients with neurological conditions, particularly hydrocephalus. We get up and come to work every day because our work matters… we are extremely fortunate to work in this space, and there’s so much more to be done. We appreciate the Hydrocephalus Association’s efforts to provide factual and educational information to patients, and we thank you for your support and understanding.

Follow Up: One Neurologist’s Experience

A big part of the recall process has been Codman’s effort to educate the medical community about the recall and what it means to their patient community. Below Dr. Williams shares his approach to addressing the recall with his patients and the impact it has had on his practice.

HA: You have chosen to contact your patients who currently have the CODMAN CERTAS Valve. What are you communicating to them?

DR. WILLIAMS: We opted to send a letter to our patients that stated that if they are anxious about the recall, they are welcome to come in for an earlier appointment. We had to figure out how many patients had the shunt. To do this, we had to ask the Operating Room staff to access the patient database to identify everyone who had the shunt implanted. My guess before they ran the database was 10 or 20 patients, but it ended up being 40 patients who had the CERTAS Valve.

HA: How has your practice been impacted or changed by the recall?

DR. WILLIAMS: As it happens, last week I had two patients who came in for routine follow up visits who have the CODMAN CERTAS Valve and I spoke to them in person about the recall. The essence of the letter we received from Codman is to say that Codman has issued a recall and the main reason is that, although the shunt design was marketed to be safe in an MRI and patients would not have to come back to their doctors following the procedure, this is not always the case. So we have changed our practice so that everyone comes back to see us after they have an MRI in any part of their body. From my perspective, it means that I need to treat the patients with the CODMAN CERTAS Valve the same way we treat patients with other programmable shunts, which is to confirm the shunt setting after an MRI. In some respects, it doesn’t change the overall practice of my office, but it does affect the 30 to 40 patients in our practice who do have the CODMAN CERTAS shunt.

As long as the shunt is at the right setting for them, it continues to work properly. They are not in danger. There is not any reason to remove or replace the shunt just because of the recall. When I reviewed the recall with my patients, they appreciated the explanation, felt reassured, and felt that we were getting information out to them.

We also decided that we would put an electronic copy of the recall notice in the patient’s electronic medical record. This is part of best practices now. This means that should one of my patients end up in our ER department, the recall notice is available to the staff. Also, should the patient move and ask for a printed copy of their record, it will be included with their medical record. For most patients, the issue is to carry their wallet card stating the kind of shunt they have and their current shunt settings.

HA: What would you like to express to our community regarding the recall?

DR. WILLIAMS: The issue of a recall can occur with any medical device that is manufactured. Over the years one company or another has had a reason to recall a valve or component. So this is not the first time that there has been a recall of a shunt or shunt components. In my own experience, this is the first time a recall has been made for the reasons Codman described – they picked up subtle problems with the manufacturing process. To Codman’s credit, they recognized that even if it’s a problem with only 6 out of every 10,000 valves, when you consider how many thousands of patients have shunts and how many dozens of times it’s reprogrammed or they have an MRI scan, there could be someone at risk.

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Comments»

1. Ronald DeLong - June 1, 2013

Thank you for the information. I will follow-up with my Physician.

2. Patricia Langdon - May 29, 2014

I had a Codman Certas Programmable Valve Shunt implanted. It worked for approximately TWO DAYS. The shunt then malfunctioned and the catheter became completely clogged, leaving me (of course) with having to have another invasive surgery to implant a new Codman Hakim Programmable Valve Shunt. I suffered for two months before the neurosurgeon listened to me and performed a shunt-o-gram. She then promptly scheduled another brain surgery and replaced the Codman Certas shunt. I know the Codman Certas only worked for two days because I only felt better for those two days. After that, I felt worse than I did before I had the surgery. Codman Certas should have to compensate people who have had to suffer due to their product defects. How many of their employees would want to have to endure an additional surgery due to product malfunction??


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