BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 4801883 · Received May 26, 2015

    Report

    Report Number
    3009448963-2015-00301
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    April 30, 2015
    Report Date
    April 30, 2015
    Manufacturer
    CAMERON HEALTH INC.
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. IT WAS CONFIRMED THAT NO TELEMETRY COULD BE ESTABLISHED WITH THE DEVICE. THE CASE WAS REMOVED, AND INTERNAL VISUAL INSPECTION FOUND NO IRREGULARITIES. BATTERY MEASUREMENTS WERE NORMAL. TESTING INDICATED A POSSIBLE ISSUE WITH THE BATTERY FUSE. THE BATTERY FUSE WAS REPLACED AND, SUBSEQUENTLY, THE DEVICE POWERED-UP AND FURTHER TESTING YIELDED NORMAL RESULTS. X-RAY EVALUATION OF THE BATTERY FUSE THAT WAS REMOVED FROM THE DEVICE CONFIRMED THAT THE FUSE HAD BEEN ACTIVATED (OPENED). THE BATTERY PACK WAS THEN REMOVED FROM THE INTERNAL CIRCUITRY AND MICROSCOPIC VISUAL INSPECTION OF THE INTERNAL COMPONENTS FOUND NO IRREGULARITIES. AS ALL TESTING YIELDED NORMAL RESULTS AFTER THE BATTERY FUSE WAS REPLACED, THE ROOT CAUSE OF THE "OPEN" CONDITION OF THE BATTERY FUSE COULD NOT BE DETERMINED. THE "OPEN" FUSE WAS THE CAUSE OF THE OBSERVED INABILITY TO TELEMETER THIS DEVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC REC'D INFO THAT PRIOR TO AN IMPLANT, WHEN SCANNING FOR DEVICES, THIS DEVICE WAS SUCCESSFULLY IDENTIFIED. THE FIELD REP THEN ATTEMPTED TO PROCEED WITH THE DEVICE SET-UP BUT WAS UNABLE TO DO SO. THE PROGRAMMER WAS REBOOTED AND ANOTHER PROGRAMMER WAS ALSO USED, BUT THE DEVICE WAS UNABLE TO BE IDENTIFIED. ANOTHER SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS IDENTIFIED, SET-UP, AND IMPLANTED WITHOUT DIFFICULTY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POTENTIAL EVALUATION OPTIONS. THE FIELD REP APPLIED MAGNET OVER THE DEVICE AND NO TONES WERE HEARD, AND ADD'L ATTEMPTS AT INTERROGATING THE DEVICE THE FOLLOWING DAY WERE UNSUCCESSFUL. THE DEVICE REMAINS IN ITS STERILE PACKAGING AND WAS GOING TO BE RETURNED FOR ANALYSIS. AS THIS WAS PRE-IMPLANT, THERE WERE NO ADVERSE PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341069 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH INC. 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 3010