BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3213010 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09913
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 AT THE IMPLANT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), HIGH IMPEDANCE WAS NOTED ON THE CHRONIC LEFT VENTRICULAR (LV) LEAD AFTER IT WAS CONNECED TO THE DEVICE. THE LEAD WAS REMOVED FROM THE HEADER AND THE PHYSICIAN OBSERVED THE SET SCREW WAS LOOSE. THE LEAD WAS REINSERTED AND CONNECTED TO THE DEVICE AGAIN WITH SET SCREWS TIGHTENED AND THE MEASUREMENTS WERE NORMAL. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313476 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR H170| 1346T| 0185| 4555| MISMATCH| N141| 1388T