BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 4870836 · Received June 24, 2015

    Report

    Report Number
    3009448963-2015-00372
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Date of Event
    April 24, 2015
    Report Date
    June 4, 2015
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. IT WAS CONFIRMED THAT THE DEVICE WAS AT EOL BATTERY STATUS. EXTERNAL VISUAL INSPECTION IDENTIFIED NO ANOMALIES. FUNCTIONAL SHOCK TESTING WAS CONDUCTED, AT WHICH TIME THE DEVICE WAS NOT ABLE TO DELIVER A FULL ENERGY SHOCK. THE DEVICE WAS DISASSEMBLED AND DETAILED ANALYSIS PERFORMED ON ALL THREE BATTERY CELLS. ONE OF THE BATTERY CELLS WAS CONFIRMED TO BE COMPLETELY DEPLETED. ENGINEERS CONCLUDED THE DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH CURRENT CONDITION, CAUSING INTERNAL CELL DEPLETION. MANUFACTURING ENHANCEMENTS, DESIGNED TO MITIGATE THE OCCURRENCE OF THIS RAPID INTERNAL CELL DEPLETION, WERE IMPLEMENTED IN 2011. THIS DEVICE WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC REC'D INFORMATION THAT THE PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) VISITED THEIR LOCAL HOSPITAL FOLLOWING A SUCCESSFUL DEVICE SHOCK CONVERSION FOR VENTRICULAR FIBRILLATION (VF). THE DEVICE WAS INTERROGATED SO AS TO REVIEW EPISODE INFORMATION, AT WHICH TIME A SOFTWARE UPGRADE WAS ATTEMPTED HOWEVER UNSUCCESSFULLY DUE TO THE OBSERVED REMAINING BATTERY CAPACITY. AS A RESULT, THE DEVICE WAS EXPLANTED. THE FIELD ALLEGED NO PERFORMANCE ANOMALIES OF THE DEVICE WHILE IMPLANTED, STATING EXPLANT WAS FOR NORMAL END OF LIFE. THE EXPLANTED DEVICE WAS RETURNED FOR POST-EXPLANT ANALYSIS, AT WHICH TIME ENGINEERS CONFIRMED A BATTERY ANOMALY. AT THE TIME OF EXPLANT, ANOTHER SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS SUCCESSFULLY IMPLANTED AND NO ADVERSE PATIENT EFFECTS NOR DEVICE ALLEGATIONS, WERE REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410409 S-ICD SYSTEM LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 3010