BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1092623 · Received August 1, 2008

    Report

    Report Number
    1028232-2008-00755
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    May 12, 2008
    Report Date
    June 18, 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

    THE MECHANICAL PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM. WITH REGARD TO THE DISLODGEMENT AS MENTIONED IN THE COMPLAINT, THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE MECHANICAL SPECIFICATIONS. THE FIXATION HELIX COULD BE FULLY EXTENDED AND RETRACTED. FURTHERMORE, THE MEASUREMENT RESULTS PROVED TO BE WITHIN THE VALVE 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFO THAT FOUR DAYS POST THE INITIAL IMPLANT PROCEDURE, THIS RIGHT VENTRICULAR LEAD DISLODGED. DURING THE ATTEMPT TO REPOSITION THE LEAD, THE PHYSICIAN FOUND THAT PT'S HEART WAS MUCH LARGER AND THE LEAD HAD TO BE ADVANCED SIGNIFICANTLY SO THE PHYSICIAN ELECTED TO USE A NEW RIGHT VENTRICULAR LEAD. NO ADVERSE PT EFFECTS WERE REPORTED.

    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