BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 1101446 · Received August 5, 2008

    Report

    Report Number
    1028232-2008-00818
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    May 22, 2008
    Report Date
    July 4, 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 FIXATION HELIX WAS FOUND DEFORMED. DUE TO THE DEFORMED FIXATION HELIX, THE FUNCTIONAL TEST OF THE FIXATION HELIX MECHANISM WAS NOT PROPERLY FEASIBLE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM. IT IS REASONABLE TO ASSUME THAT THE DEFORMED HELIX IS DUE TO EXCESSIVE MECHANICAL STRESS DURING THE IMPLANTATION OR EXPLANTATION PROCEDURE. THE CUTTINGS IN THE OUTER INSULATION ARE MOST LIKELY DUE TO THE EXPLANTATION PROCEDURE.

    Description of Event or Problem · 1

    PER INCIDENT REPORT, THIS LEAD HAD DISLODGED ONE DAY POST IMPLANT AND WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACER LEAD DTB BIOTRONIK GMBH AND CO 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization