BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3210364 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08269
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROGRAMMING CHANGES WERE MADE AND ACCEPTABLE PACING IMPEDANCE MEASUREMENTS OF 609 OHMS WERE OBTAINED. AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. 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 A ROUTINE DEVICE REPLACEMENT, UPON CONNECTION OF A LEFT VENTRICULAR (LV) ADAPTER TO THE CHRONIC LV LEAD AND INSERTION INTO THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), DIFFICULTY WAS ENCOUNTERED WITH TIGHTENING THE PROXIMAL SET SCREW. ADDITIONALLY, HIGH OUT OF RANGE LV PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS WAS OBSERVED. AN ATTEMPT WAS MADE TO REPOSITION THE PIN IN THE HEADER AND THE ADAPTER, HOWEVER, THE SET SCREW WAS UNABLE TO BE LOOSENED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309693 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4403| N141| 0184| H215| 4517| 4135| 4469