BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212502 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08447
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS AVAILABLE AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION LESS THAN TWO MONTHS AGO, THIS PATIENT CAME TO THE HOSPITAL IN THE MORNING FOLLOWING THE PREVIOUS EVENING WHERE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCKED HIM. HE ALSO REPORTED PREVIOUSLY THE ICD EMITTED BEEP TONES. UPON INTERROGATION AT THE HOSPITAL, THE DEVICE REVERTED TO A RESET SAFETY MODE; HOWEVER, IT REMAINED UNCLEAR WHICH TYPE OF RESET HAD OCCURRED. THE FOLLOWING DAY, THE ICD WAS EXPLANTED, REPLACED, AND RETURNED FOR ANALYSIS. THE CHRONIC LEADS WERE RECONNECTED TO THE NEW DEVICE AND TESTED SUCCESSFULLY. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED. THE ICD WAS SUBSEQUENTLY RETURNED ONE AND ONE HALF MONTHS LATER FOR ANALYSIS. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED AN ARC MARK ON THE DEVICE CASE. ADDITIONALLY, ANALYSIS CONFIRMED AN INABILITY TO COMMUNICATE WITH THE DEVICE. ELECTRICAL TESTING PERFORMED INDICATED A BATTERY VOLTAGE OF 1.1V, AND VERIFIED THAT THE SHOCKING OUTPUT BRIDGE WAS INTACT. HOWEVER, AS THE ARCING ON THE DEVICE CASE WAS DIRECTLY OVER THE DEVICE CIRCUITRY, THE ARCING CAUSED INTERNAL DEVICE DAMAGE AND RESULTED IN THE OBSERVED SAFETY MODE OPERATION. BOSTON SCIENTIFIC'S HISTORICAL TREND DATA INDICATES THAT THE CAUSE OF ARCING DAMAGE LIKE THAT SEEN WITH THIS DEVICE IS AN EXTERNAL HIGH VOLTAGE SHORT WHICH MAY CAUSE INTERNAL DAMAGE TO THE CIRCUITRY. THE DAMAGE TO THE DEVICE WAS MOST LIKELY DUE TO A SHORTED LEAD CONDITION THAT OCCURRED DURING DELIVERY OF A SHOCK. DEVICES ARE NOT EXPECTED TO PERFORM TO SPECIFICATION POST-ARCING EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314409 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 F110| MISMATCH| T165| 0148