BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2212891 · Received July 12, 2011

    Report

    Report Number
    1028232-2011-01528
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    February 10, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE ARRHYTHMIA LOGBOOK NOTED EPISODES OF NON-CAPTURE WITH INTRINSIC CONDUCTION. THESE EPISODES DATE BACK TO 2008. THE THRESHOLD WAS FOUND TO BE 3V AT .3MS AND WAS REPROGRAMMED TO 3V AT .9MS. THE RIGHT VENTRICULAR LEAD WAS SUSPECTED TO BE POSITIONED IN THE APEX AS THERE IS PSEUDOFUSION WHEN THE AV DELAY IS PROGRAMMED TO 300MS. A CHEST X-RAY WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE NOTED. INFORMATION WAS LATER RECEIVED THAT THIS LEAD WAS EXPLANTED DUE TO A FRACTURE UNDER THE SUTURE COLLAR. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization