Boston Scientific Corp. (NYSE: BSX) sent out an advisory to physicians about reported problems with the connections on pacemakers implanted beneath the pectoral muscle.
The company said it received two reports of weakened connections between the pacemakers’ header and case, caused by the device being squeezed between the chest muscles and the ribcage.
No deaths have been reported, but Boston Scientific said that a weakened bond can lead to, “Significant changes in measured lead impedance. Noise on real-time or stored electrograms. Intermittent inhibition of pacing. Inappropriate anti-tachy pacing or shock therapy. Loss of pacing therapy. Loss of anti-tachy pacing and shock therapy.”
Devices said to be at risk are:
- Cognis models N106/N107/N108/N118/N119/P106/P107/P108
- Teligen VR models E102/F102
- Teligen DR models E110/F110/E111/F111
Only devices implanted sub-pectorally are said to be at risk for weakened connections. BSX said only about 5 percent of the 77,000 Cognis and Teligen devices were implanted beneath the chest muscles; implants placed subcutaneously are not at risk. Larger, more muscular patients and more active patients with the sub-pectoral implantation may be at greater risk, the company added.
Boston Scientific is advising physicians to avoid subpectoral implementation until it can make improvements to the devices and to have patients with the implants to check in once every three months and report any shocks they receive.