BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3210353 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07751
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 17, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY EVALUATED. VISUAL INSPECTION OF THE DEVICE HEADER AND CASE DID NOT REVEAL ANY ANOMALIES. IT WAS CONFIRMED THAT THE DEVICE HAD NO TELEMETRY AND A MEMORY DOWNLOAD COULD NOT BE PERFORMED. THE DEVICE CASE WAS OPENED IN ORDER TO ASSESS THE INTERNAL COMPONENTS. INITIAL ELECTRICAL TESTING REVEALED THAT THE TRANSFORMER HAD FAILED, RESULTING IN ELECTRICAL OVERSTRESS DAMAGE TO THE POWER SUPPLY CIRCUITRY. DETAILED ANALYSIS DETERMINED THE INABILITY TO INTERROGATE THIS DEVICE AND ABSENCE OF MAGNET TONES WERE DUE TO THE ELECTRICAL OVERSTRESS DAMAGE. THIS RESULTED IN A HIGH CURRENT DRAIN, WHICH DEPLETED THE BATTERY MORE QUICKLY THAN EXPECTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) COULD NOT COMPLETE A REMOTE HOME MONITORING INTERROGATION. THE PATIENT WAS REFERRED TO THEIR CLINIC FOR AN IN-OFFICE INTERROGATION WHICH WAS ALSO UNSUCCESSFUL. A MAGNET WAS PLACED OVER THE DEVICE AND NO BEEP TONES COULD BE HEARD. A SECOND PROGRAMMER WAS USED AND COMMUNICATIONS WITH THE DEVICE WERE STILL UNSUCCESSFUL. AT THIS POINT THE PHYSICIAN SUSPECTED A NON-FUNCTIONING DEVICE, THEREFORE EXPLANTED AND REPLACED IT WITH A NEW DEVICE. ATTEMPTS TO INTERROGATE THE DEVICE AFTER IT WAS EXPLANTED WERE STILL UNSUCCESSFUL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310476 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R E140| 0295