BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 2910370 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15700
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 29, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT 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, ABSENT OF MAGNET TONES AND NO PACING 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) COULD NOT BE INTERROGATED, COULD NOT PACE AND COULD NOT EMIT BEEPING TONES UPON MAGNET APPLICATION AFTER APPROXIMATELY SEVEN MONTHS OF IMPLANT. TROUBLESHOOTING PERFORMED WAS UNSUCCESSFUL. SINCE THE DEVICE WAS NO LONGER FUNCTIONAL, IT WAS REPLACED. THE HIGH VOLTAGE LEAD SYSTEM WAS TESTED ONCE THE NEW DEVICE WAS IMPLANTED AND ALL VALUES WERE NORMAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17071 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 4136| MISMATCH| 0185| T175| 4548| N141