BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 2221363 · Received August 24, 2011

    Report

    Report Number
    3005099803-2011-02774
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A ANTERIOR REPAIR PROCEDURE USING A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT, AS THE PHYSICIAN WAS PLACING A LEG ASSEMBLY THROUGH THE PATIENT'S SACROSPINOUS LIGAMENT, THE DILATOR DETACHED. REPORTEDLY, THE DETACHED DILATOR REMAINED GRASPED BY HEMOSTATS AND DID NOT FALL LOOSE INSIDE THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE.

    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 ML00000127

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR