The problem seems to be that the bond between the translucent header (which holds the leads) and the metal case (which contains the pulse generator) can be weakened by a patient's pectoral muscles pushing against the ribcage.
No deaths have been reported. And, to date, there have only been two reports worldwide of implants with weakened header bonds. The patients implanted with these devices received inappropriate shocks and required early device replacement.
Boston Scientific has already notified doctors and the FDA. In fact, they have already submitted manufacturing process improvements to the FDA, and will implement those changes when regulatory approval is received.
According to Boston Scientific, a weakened header bond can 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
- If you don't already know what type of device you have, check your ID card to determine whether you have a COGNIS or a TELIGEN. If you don’t have either, this advisory does not apply to you.
- Talk to your doctor to determine whether your device is implanted under the skin (subcutaneous implant), or under the chest muscle (subpectoral implant). The odds are in your favor. Most devices (95%) are placed under the skin. Only about 5% are placed under the pectoral muscle. If your device is implanted just under the skin, this advisory does not apply to you.
- Attend your regular device follow-up appointments
- Immediately contact your device doctor or clinic if you receive a shock
More details, including contact information and phone numbers on the blog, here: