BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3210183 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06865
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    June 21, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS VERIFIED THE DEVICE WAS RETURNED IN SAFETY MODE (I.E., SAFETY CORE). EXAMINATION OF THE DEVICE MEMORY REVEALED THE DEVICE HAD REVERTED TO SAFETY CORE AS A RESULT OF THREE CONSECUTIVE STUCK PROCESS SYSTEM FAULTS THAT OCCURRED OVER THE WEEKEND OF (B)(6) 2013. SAFETY CORE OPERATION BEGAN ON (B)(6) 2013. THIS SAFETY CORE CONDITION WAS DUE TO THE DEVICE BEING LEFT IN A ¿PG PROGRAMMER TELEMETRY SESSION¿ FOR LONGER THAN 75 HOURS WHICH RESULTED IN THE STUCK PROCESS SYSTEM FAULTS AND THE DEVICE REVERTING TO SAFETY CORE. IF A DEVICE IS LEFT IN A SESSION INDEFINITELY WITH THE WAND IN PLACE, THE DEVICE WILL REVERT TO SAFETY CORE BY DESIGN. FURTHER DETAILED TESTING WAS PERFORMED. THE DEVICE WAS PROGRAMMED OUT OF THE SAFETY MODE AND PUT THROUGH A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIED THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING AND RECORDING FUNCTIONS OF THE DEVICE WHICH REVEALED NORMAL DEVICE FUNCTION.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED ADN THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE PRE-IMPLANT TESTING, A FAULT CODE WAS DISPLAYED INDICATING THIS DEVICE WAS IN SAFETY CORE. THIS DEVICE WAS NOT IMPLANTED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310905 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F140

    Patients

    Seq Age Sex Outcome Treatment
    1