BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 1211768 · Received October 24, 2008

    Report

    Report Number
    1028232-2008-01289
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    August 23, 2008
    Report Date
    September 26, 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. WITH REGARD TO THE ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION, 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 CUTTINGS IN THE OUTER INSULATION ARE MOST LIKELY DUE TO THE IMPLANTATION PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD WAS BEING REPOSITIONED ONE DAY POST IMPLANT DUE TO POOR SENSING MEASUREMENTS. WHEN THE PHYSICIAN OPENED THE POCKET, THE LEAD'S INSULATION WAS INADVERTENTLY CUT. THIS LEAD WAS EXPLANTED, AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. TO DATE, 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