BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KIT

    MDR report key: 1293029 · Received January 15, 2009

    Report

    Report Number
    3005099803-2009-00180
    Event Type
    Injury
    Date Received
    January 15, 2009
    Date of Event
    December 8, 2008
    Report Date
    December 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT 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 FOLLOWING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE USING A PINNACLE PFK KIT, THE PATIENT WAS IN RETENTION. THE PHYSICIAN DOESN'T KNOW IF THE RETENTION WAS DUE TO THE PINNACLE DEVICE OR THE BARD ALIGN TO SLING PLACED FOR INCONTINENCE DURING THE SAME PROCEDURE. THE PATIENT SAW A NURSE PRACTITIONER IN LATE 2008. PER THE PHYSICIAN, "CATHETER IS OUT. SHE IS VOIDING. PVR (POSTVOID RESIDUAL URINE VOLUME) WAS ZERO IN THE OFFICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KIT FTM BOSTON SCIENTIFIC CORPORATION M0068317050 OML8101501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention BARD ALIGN TO SLING