BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 1860045 · Received October 7, 2010

    Report

    Report Number
    3005099803-2010-04299
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POSTERIOR PELVIC FLOOR REPAIR PROCEDURE WAS PERFORMED SOMETIME IN (B)(6) 2010 (EXACT DATE UNKNOWN), USING A PINNACLE POSTERIOR PFR KIT, BY A DR (B)(6) AT (B)(6) HOSPITAL. FOLLOWING THE INITIAL PROCEDURE, THE PATIENT'S CONDITION WAS REPORTEDLY "GOOD." ON (B)(6) 2010, THE PATIENT WAS REFERRED TO DR (B)(6) AT (B)(6) MEDICAL CENTER. SHE PRESENTED WITH "VERY MINIMAL" VAGINAL BLEEDING AND A MESH EXTRUSION. THE VAGINAL BLEEDING STOPPED WITHOUT NEED FOR INTERVENTION, BUT THE PHYSICIAN EXCISED 0.8 CENTIMETER BY 1.2 CENTIMETER OF THE MESH EXTRUSION FROM THE PATIENT. THE PATIENT IS NOW REPORTEDLY "GOOD" AND "EVERYTHING HAS RESOLVED."

    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 56 YR Required Intervention