BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4135

    MDR report key: 1020481 · Received March 28, 2008

    Report

    Report Number
    1028232-2008-00326
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    January 30, 2008
    Report Date
    March 3, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MECHANICAL PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. PARTICULARLY WITH REGARD TO 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 CUTTINGS IN THE OUTER INSULATION ARE MOST LIKELY DUE TO THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    BSC CRM REPORTED THAT, WHILE NO REP WAS PRESENT FOR THIS CASE, THE LAB STAFF DID REPORT THAT THE LEAD REPEATEDLY BECAME DISLODGED AND IT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD DTB BIOTRONIK GMBH AND CO. 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization