Devices

Alert on Boston Scientific Defibrillation Leads

FDA has issued an early alert based on a Boston Scientific letter to customers about certain Endotak Reliance defibrillation leads with expanded polytetrafluoroethylene (ePTFE) coated coils that may impact shock efficacy or require early replacement. The leads are intended for pacing, rate-sensing, and delivery of cardioversion and defibrillation shocks when used with a compatible pulse generator.

The company is aware of the association of calcified defibrillation lead coils with a pattern of gradually rising low-voltage shock impedance (LVSI) measurements, the notice says. “This calcification phenomenon can biologically encapsulate and electrically insulate the defibrillation lead coil(s),” it says.

Boston Scientific has completed a comprehensive investigation of ePTFE Reliance lead performance to identify the early signs of this phenomenon, characterize its potential effect on shock efficacy, and provide recommendations to mitigate the associated risk, the agency says, including routine follow-up of defibrillation systems with ePTFE leads either through in-person or remote monitoring.

The notice says the most common harm is early lead replacement, and the most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from a reduced shock energy due to high impedance. To date, Boston Scientific has reported 386 serious injuries and 16 patient deaths associated with the issue, it says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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