BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3922080 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12539
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 10, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE FOR THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD, DEFIBRILLATION THRESHOLD (DFT) TESTING FAILED NUMEROUS TIMES. THE PATIENT WAS REQUIRED TO BE EXTERNALLY RESCUED. SUBSEQUENTLY, THE DEVICE DELIVERED AN ADDITIONAL SHOCK AFTER OVERSENSING NOISE OF AN UNKNOWN SOURCE. INTERMITTENT LOSS OF CAPTURE (LOC) WAS ALSO NOTED POST SHOCK. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED POTENTIAL CAUSES OF THE CLINICAL OBSERVATIONS. THE DEVICE AND LEAD WERE SUCCESSFULLY IMPLANTED AND REMAIN IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401134 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E142

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 4135| E142| 0295