BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS

    MDR report key: 1012767 · Received March 12, 2008

    Report

    Report Number
    1028232-2008-00328
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MECHANICAL PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. PARTICULARLY WITH REGARD TO THE HELIX DIFFICULTIES AS WELL AS LEAD DISLODGEMENT AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE INVESTIGATIONS DID NOT SHOW ANY DEVIATIONS FROM THE MECHANICAL SPECIFICATIONS. THE FIXATION HELIX COULD BE PROPERLY 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 ANALYSIS DID NOT REVEAL ANY SIGH OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THE HELIX WAS NOT MOVING SMOOTHLY; IT KEPT JUMPING OUT AFTER 23-30 TURNS BEFORE HELIX WOULD POP OUT. IT WOULD NOT GET A BITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1