BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KIT

    MDR report key: 1140650 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04178
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K071957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE USING THE PINNACLE PFR KIT, THE BULLET DETACHED WHEN IT WAS THROWN THROUGH THE SACROSPINOUS LIGAMENT. THE PHYSICIAN RETRIEVED THE BULLET AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME TYPE OF DEVICE WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KIT FTM BOSTON SCIENTIFIC CORPORATION M0068317050 0ML8051603

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR