BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 1792143 · Received August 10, 2010

    Report

    Report Number
    3005099803-2010-03459
    Event Type
    Injury
    Date Received
    August 10, 2010
    Report Date
    July 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED 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

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT #3005099803-2010-03460 FOR A DESCRIPTION OF THE SECOND DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SUCCESSFUL POSTERIOR PELVIC FLOOR REPAIR PROCEDURE WAS PERFORMED ON (B)(6) 2010, USING A PINNACLE POSTERIOR PFR KIT, WHICH WAS PLACED "SUCCESSFULLY WITHOUT ISSUE." DURING THE WEEK OF (B)(6) 2010, THE PATIENT WAS SEEN BY ANOTHER PHYSICIAN, A DR (B)(6). DURING RECTAL PALPATION, THE PHYSICIAN FELT WHAT S/HE BELIEVED TO BE A SECTION OF THE MESH PERFORATING THE RECTAL WALL. THE PHYSICIAN SUSPECTS THAT THE RECTUM WAS PERFORATED DURING THE PLACEMENT OF THE MESH. THERE HAS BEEN NO FURTHER INTERVENTION, BUT THE PHYSICIAN PLANS TO PERFORM A SECOND PROCEDURE TRANSVAGINALLY IN THE POSTERIOR COMPARTMENT TO REMOVE THE MESH FROM THE RECTUM. THE PATIENT IS REPORTEDLY "DOING WELL" AND IS BEING MONITORED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PINNACLE ANTERIOR/APICAL PFR KIT