FDA Provides Early Alert On Defibrillation Lead Issue From Boston Scientific

FDA:

• FDA: PROVIDES EARLY ALERT ON DEFIBRILLATION LEAD ISSUE FROM BOSTON SCIENTIFIC

• FDA: CERTAIN ENDOTAK RELIANCE DEFIBRILLATION LEADS WITH EXPANDED EPTFE COATED COILS MAY IMPACT SHOCK EFFICACY AND/OR REQUIRE EARLY REPLACEMENT

• FDA: AS OF JULY 24, BOSTON SCIENTIFIC REPORTED 386 SERIOUS INJURIES, 16 PATIENT DEATHS ASSOCIATED WITH DEFIBRILLATION LEAD ISSUE- WEBSITE