BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 2212198 · Received August 15, 2011

    Report

    Report Number
    3005099803-2011-02717
    Event Type
    Injury
    Date Received
    August 15, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT #3005099803-2011-02792 PERTAINS TO THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A HYSTERECTOMY AND VAGINAL RECONSTRUCTION PROCEDURE ON (B)(6) 2008, THE PATIENT WAS IMPLANTED WITH A PINNACLE PELVIC FLOOR REPAIR KIT (EXACT TYPE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH MESH EROSION IN (B)(6) 2009, AND AT THAT TIME, THE PHYSICIAN ATTEMPTED TO TRIM PARTS OF THE MESH THAT WERE PROTRUDING THROUGH THE VAGINAL WALL. THE PATIENT HAD ADDITIONAL SURGERY (TYPE UNKNOWN) ON (B)(6) 2009, TO TREAT STRESS URINARY INCONTINENCE AND CHRONIC PAIN (TYPE UNKNOWN). ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN AND REPORTEDLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK558

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PREFYX PRE-PUBIC SLING SYSTEM