Some patients are having their defibrillation leads taken out early due to shock coil calcification, according to an FDA alert .

Boston Scientific has informed healthcare providers that device leads coated with expanded polytetrafluoroethylene (ePTFE) are showing signs of calcification, resulting in a pattern of gradually rising low-voltage shock impedance (LVSI) measurements.

Calcification is therefore potentially making some defibrillation lead coils electrically insulated, impacting shock efficacy and/or requiring early replacement. 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 caused by high impedance, the company said.

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