BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2170730 · Received July 12, 2011

    Report

    Report Number
    1028232-2011-01527
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    May 25, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED AS A RATE/SENSE LEAD DUE TO UNDERSENSING OF FINE VENTRICULAR FIBRILLATION (VF). AFTER IMPLANT, THIS LEAD ALSO EXHIBITED UNDERSENSING OF FINE VENTRICULAR FIBRILLATION (VF). THE LEAD WAS FOUND TO HAVE DISLODGED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED AND RETURNED. THE DATE OF EXPLANT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization