BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1181624 · Received September 29, 2008

    Report

    Report Number
    1028232-2008-01142
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 29, 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. 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 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 EXPLANATION PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEXTRUS ATRIAL LEAD DISLODGED. IN A REVISION PROCEDURE, THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. NO ADVERSE PATIENT 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