BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KIT

    MDR report key: 1071612 · Received July 9, 2008

    Report

    Report Number
    3005099803-2008-01104
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    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; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR 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 PHYSICIAN COULD NOT GET THE NEEDLE THROUGH THE LIGAMENT, AND WHEN HE PULLED THE NEEDLE BACK, IT DETACHED INSIDE THE PATIENT AND COULD NOT BE LOCATED OR RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, AND THE PATIENT IS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KIT FTM BOSTON SCIENTIFIC CORPORATION M0068317050 OML8041402

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other