Wednesday, December 9, 2009

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.

2 comments:

Anonymous said...

Do you have an update on this advisory, which is now an FDA class II call?

Hugo Campos said...

Thanks for your comment. As far as I can tell, and based on information available on BSC's web site, nothing has changed.

As of today, Boston Scientific's "Product Advisories" document available on their web site says that FDA Classification is "Pending"

Download it below:
http://bit.ly/aT6oc6