Boston Scientific advisory issued on the COGNIS and TELIGEN families of ICDs.

Boston Scientific has notified the ICD User Group of an important product advisory involving their COGNIS CRT-Ds and TELIGEN ICDs.

This product advisory information is not a recall, and affects only COGNIS and TELIGEN devices implanted below the chest muscles (commonly known as submuscular pectoral, or subpectoral implants). Devices placed subcutaneously (just under the skin) are not affected by this advisory.

About 95% percent of defibrillators are implanted subcutaneously. Less commonly, a doctor may choose to implant a device deeper, under the chest muscles. Boston Scientific has learned that devices implanted under the chest muscles may be subject to mechanical stress that could weaken the bond between the device casing and the lead connector, or header, portion of the device, and could impact the ability to deliver appropriate therapy.

According to Boston Scientific, a weakened header bond can also result in one or more of the following:

• Significant changes in measured lead impedance
• Noise on real-time or stored electrograms
• Intermittent inhibition of pacing
• Inappropriate anti-tachycardia pacing or shock therapy
• Loss of pacing therapy
• Loss of anti-tachycardia pacing and shock therapy

To date, Boston Scientific says it has received only two reports worldwide of implants located under the chest muscles with weakened header bonds. The patients implanted with these devices received inappropriate shocks and were required to have their devices replaced earlier than expected.

Boston Scientific has notified regulatory authorities of this problem and has communicated this issue to physicians. They have also submitted manufacturing process improvements to the FDA and will implement such changes when regulatory approval is received.

Again, only COGNIS and TELIGEN devices implanted below the chest muscles are affected by this advisory. Boston Scientific estimates that this consists of only about 5% of the 77,000 devices implanted worldwide.

WHAT YOU SHOULD DO:

• If you don’t already know what device model you have, check your ID card to determine whether you have a COGNIS or TELIGEN. If you don’t, this advisory does not apply.


• Talk to your doctor to determine whether your device is implanted under the skin, or under the chest muscle. If your device is implanted just under the skin, this advisory does not apply.


• Attend your regular device follow-up appointments


• Immediately contact your device doctor or clinic if you receive a shock

This advisory is publicly available on Boston Scientific’s website, under the Product Performance Resource Center link. A PDF of current Product Advisories can be downloaded here.

In addition to the above, Boston Scientific’s Patient Advocacy & Education and Patient Services teams are available to support you and answer any questions you may have. Patients should contact Boston Scientific Patient Services at 1 (866) 484-3268. Press “2” when prompted.

In an email to the ICD User Group, Boston Scientific explained that it’s taken the initiative to inform us in hopes that the information will get out there in a resposible and accurate manner. They’ve also stated that they recognize the importance of advocacy groups as an “important and credible resource for patients.”

Here’s a link to this Product Advisory on Boston Scientific’s web site.

Read all »

Medtronic Advisory issued on the Concerto and Virtuoso (UPDATED)

Yesterday, Medtronic issued a Physician Communication to doctors who implant Concerto CRTDs and Virtuoso ICDs regarding a batch of devices from 2005 and 2006 in which faulty battery capacitors were used. The capacitors in the affected devices were manufactured by an outside vendor, and more recent models of these devices no longer use this component.

The problem seems to affect only about 6,300 devices and may cause premature battery depletion. Medtronic recommends that physicians follow-up the affected devices every three months and that the patient alert feature be programmed "ON-High" (this is what the alarm sounds like) for the Low Voltage Battery alert.

As reported by Dr. Wes (who, by the way, scooped the WSJ), this is not a recall and it suggests none of the affected devices have failed or caused deaths.

Click here to see if your Concerto CRT device or Virtuoso ICD is affected.

This is the link, if you prefer to copy and paste it:
http://CVSNList.medtronic.com

UPDATE (10:51 AM PDT):

I just got some additional information on this. Medtronic reiterates that there is no safety issue here. This is not a recall and patients don't have to do anything other then they're already doing. Medtronic is not recommending prophylactic explant or anything like that because there will be no sudden loss of output and the devices will function and deliver therapy as needed.

Also, Medtronic has said they intend to honor the warranty on these devices and provide reasonable unreimbursed medical coverage for patients who must have the devices replaced early due to this advisory.

Again, look up your device's serial number at http://CVSNList.medtronic.com. If your device is affected, you'll likely receive a letter from Medtronic.

Here's a little more context:

There have been more than 200,000 Concerto CRTDs and Virtuoso ICDs implanted worldwide. Medtronic has identified 6,300 worldwide that may be impacted (a little over 3% of all Concertos and Virtuosos).

You are right about the copper supplier; unfortunately, we don't name our suppliers contractually (it was a copper supplier to one of our other component suppliers). The copper used in the remaining devices doesn't have the same porosity issue.

I just obtained a copy of the letter to physicians:

And here's Medtronic's official statement:

Medtronic notified physicians that a relatively small number of Concerto CRT-Ds (cardiac resynchronization therapy-defibrillators) and Virtuoso ICDs are not lasting as long as projected. Affected devices may have a higher than normal current drain on the battery due to a specific component issue. However, this gradual current drain on the device battery does not pose a patient safety concern, and there have been no reports of patient injuries. There is no risk of sudden loss of output and these devices will continue to deliver therapy as needed until they reach End of Service (EOS). Patients do not have to do anything differently. They should keep up with their regular device check-ups.

Read all »

Sprint Fidelis Leads Linked to 13 Deaths

Medtronic has acknowledged that 13 people may have died in connection with the Sprint Fidelis lead.

Sprint Fidelis Defibrillator leads were approved by the FDA in 2004 and manufactured for a little over 3 years, from September of that year to October 2007. In early 2007, it was reported that the leads might have been fracturing at a higher rate than Medtronic's other leads. This eventually lead to a recall.

The New York Times reports that about 150,000 in this country still have the Sprint Fidelis lead. This number includes members of our local ICD group.

A fractured lead can cause a patient's death if it precludes the ICD from detecting a dangerous arrhythmia, thus preventing it from delivering a lifesaving shock. It can also cause the ICD to fire for no reason, delivering an unnecessary shock.

Full NY Times article here.

Read all »