BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 2960372 · Received February 14, 2013

    Report

    Report Number
    3005099803-2013-00862
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES IMPLANTED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT #S 3005099803-2013-00861 AND 3005099803-2013-00863 PERTAIN TO THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT THE PATIENT WAS IMPLANTED WITH AN UPHOLD VAGINAL SUPPORT SYSTEM, A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT, AND A SOLYX SINGLE INCISION SLING SYSTEM DURING A PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS (SPECIFICS UNKNOWN). ACCORDING TO THE PHYSICIAN, HE FIRST SAW THE PATIENT IN 2010 FOR COMPLETE VAGINAL PROLAPSE WITH BOTH STRESS AND URGE URINARY INCONTINENCE (MIXED INCONTINENCE DISORDER). A TENSION-FREE VAGINAL TAPE (TVT) PROCEDURE WITH ANTERIOR AND POSTERIOR REPAIR WAS PERFORMED ON (B)(6) 2011, AT WHICH TIME THE THREE BSC PRODUCTS LISTED ABOVE WERE USED. THE PATIENT WAS LAST SEEN ON (B)(6) 2012, AND SHE COMPLAINED OF URGE INCONTINENCE ONLY. IT WAS REPORTED THAT THERE WAS NO REMAINING EVIDENCE OF PROLAPSE OR STRESS URINARY INCONTINENCE. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64181 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317100

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other UPHOLD VAGINAL SUPPORT SYSTEM| SOLYX SINGLE INCISION SLING SYSTEM