Boston Scientific Dips, FDA Aware of Defibrillation Issue (1)

(Adds stock move.)

Boston Scientificshares slip as much as 3.1% after the FDA said it is aware of a letter to customers that said some endotak reliance defibrillation leads with expanded polytetrafluoroethylene coated coils may impact shock efficacy, according to an alert on the agency’s website.

• Most common harm is early lead replacement
  • 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”
• Boston Scientific reported 386 serious injuries and 16 patient deaths associated with the issue as of July 24
• NOTE: ...