BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 5192258 · Received October 30, 2015

    Report

    Report Number
    3009448963-2015-00608
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 3, 2015
    Report Date
    October 3, 2015
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    UDI-DI
    00802526562808
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS NOT REPORTED WHETHER THE DEVICE WAS EXPLANTED OR BURIED WITH THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED OF THE FIELD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) PASSED AWAY APPROXIMATELY FIVE DAYS POST-IMPLANT. THERE WERE NO REPORTED ALLEGATIONS. THE DEVICE WAS INTERROGATED POST-MORTEM AND IT WAS NOTED THE PATIENT HAD 40 SHOCKS OVER 15 DIFFERENT EPISODES. DEVICE DATA WAS REVIEWED BY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). PRIOR TO THE FIRST EPISODE, THE PATIENT HAD APPROXIMATELY 8 MINUTES OF NO ELECTRICAL ACTIVITY. THE FIRST EVENT WAS UNTREATED. IN ALL OTHER EPISODES, THE RHYTHM APPEARED SIMILAR IN MORPHOLOGY TO EITHER CARDIOPULMONARY RESUSCITATION (CPR), AGONAL, OR A SLOW VENTRICULAR TACHYCARDIA (VT) (BELOW THE THERAPY ZONE RATE-CUTOFF). IT APPEARED THE DEVICE WAS OVER-COUNTING. THE CAUSE OF DEATH IS STILL UNDER INVESTIGATION. THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. THE FIELD REPRESENTATIVE CONFIRMED THAT PER HIS KNOWLEDGE, THERE WERE NO ALLEGATIONS FROM THE PHYSICIAN. THE FIELD REPRESENTATIVE CONFIRMED THE PATIENT WAS SUCCESSFULLY DISCHARGED FROM THE HOSPITAL POST-IMPLANT. THE CAUSE OF DEATH IS STILL NOT KNOWN. THE DEVICE WAS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT HAD A MEDICAL HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THE PATIENT NEVER HAD BRADYCARDIA WHILE IN THE HOSPITAL. IMPLANT DEFIBRILLATION THRESHOLD (DFT) TESTING WAS SUCCESSFUL AND IT WAS BELIEVED THAT THE S-ICD WAS THE CORRECT DEVICE CHOICE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721095 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010 00802526562808

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 3010