BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KIT

    MDR report key: 1221508 · Received November 5, 2008

    Report

    Report Number
    3005099803-2008-06059
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K071957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS COMPLETED BY THE MANUFACTURER BASED ON INFORMATION OBTAINED FROM THE COMPLAINANT. THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AT THIS TIME. WE ARE NOT YET ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A PINNACLE PELVIC FLOOR REPAIR KIT WAS USED DURING AN ANTERIOR FLOOR REPAIR PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE PHYSICIAN WENT TO THROW THE FIRST SACROSPINOUS LIGAMENT LEG, THE SUTURE TIP OF THE LEG CAME OFF IN THE CAPIO DEVICE AND WOULD NOT COME OUT, AS THE SUTURE HAD NOT GONE THROUGH. THE PHYSICIAN OPENED A NEW PINNACLE KIT AND COMPLETED THE PROCEDURE WITH NO PT COMPLICATIONS. THE COMPLAINANT REPORTED THAT THERE WERE NO ADVERSE AFFECTS TO THE PT AS A RESULT OF THE REPORTED MALFUNCTION. THE PT'S CONDITION WAS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KIT FTM BOSTON SCIENTIFIC CORPORATION M0068317050 OML8072901

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR