BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1260632 · Received December 9, 2008

    Report

    Report Number
    1028232-2008-01604
    Event Type
    Injury
    Date Received
    December 9, 2008
    Date of Event
    September 19, 2008
    Report Date
    November 12, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH THE MECHANICAL AND THE ELECTRICAL PERFORMANCE OF THE LEAD UNDER COMPLAINT WERE SCRUTINIZED. THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE ELECTRICAL SPECIFICATIONS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM. THE FIXATION HELIX COULD BE FULLY EXTENDED AND RETRACTED. FURTHERMORE, THE MEASUREMENT RESULTS PROVED TO BE WITHIN THE VALUE RANGE DEFINED BY THE DESIGN SPECIFICATIONS, EVEN THOUGH COAGULATED BLOOD AND TISSUE RESIDUALS WERE FOUND WITHIN THE LEAD TIP THAT MAY COMPROMISE THE EFFECTIVENESS OF THE FIXATION SCREW MECHANISM. THE CUTTINGS IN THE OUTER INSULATION AND THE DEFORMED OUTER COIL ARE MOST LIKELY DUE TO THE EXPLANTATION PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC REPORTED THAT THIS LEAD HAD DISLODGED. IT WAS SUCCESSFULLY REPOSITIONED, BUT THEN HAD DISLODGED AGAIN AND WOULD BE REPLACED WITH ANOTHER LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK GMBH AND CO. 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization