BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35CM BIPOLAR LEAD

    MDR report key: 1172286 · Received September 19, 2008

    Report

    Report Number
    2183787-2008-00012
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    June 2, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ENPATH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K925099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. NO ANOMALIES WERE FOUND. IT CANNOT BE DETERMINED WHETHER THE RISE IN THRESHOLDS WAS RELATED TO DEVICE PERFORMANCE, OR PATIENT CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED AND REPORTED THE FOLLOWING INFORMATION: "A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD PACING THRESHOLDS WERE >7V @ 2MS, CAUSING THE DEVICE TO DEPLETE EARLIER THAN LABELING INDICATED. INSULATION DAMAGE WAS NOTED ON THE ATRIAL LEAD. A KINK WAS SEEN IN THE RIGHT VENTRICULAR DEFIBRILLATION LEAD; THERE WERE NO CLINICAL OBSERVATION AND THE LEAD WAS ELECTIVELY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 35CM BIPOLAR LEAD BIPOLAR LEAD DTB ENPATH MEDICAL 511211

    Patients

    Seq Age Sex Outcome Treatment
    1