BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 2991266 · Received March 6, 2013

    Report

    Report Number
    3005099803-2013-01440
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH A PINNACLE ANTERIOR PELVIC FLOOR REPAIR KIT AND A SOLYX SINGLE INCISION SLING SYSTEM DURING A PROCEDURE ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS (SPECIFICS UNKNOWN). IT WAS REPORTED THE PATIENT WAS ORIGINALLY SEEN FOR GRADE 3-4 CYSTOCELE. ON (B)(6) 2011 THE PATIENT WAS SEEN FOR COMPLAINTS OF NOCTURIA BUT NO INCONTINENCE WAS PRESENT. AN EXAM REVEALED A SMALL MESH EROSION. ON (B)(6) 2011 THE PATIENT UNDERWENT SURGERY TO EXCISE A SMALL PIECE OF VISIBLY ERODED MESH. THE PATIENT WAS SEEN ON (B)(6) 2011 AND WAS VOIDING FINE. THE FOLEY CATHETER WAS REMOVED AT THIS TIME. THE PATIENT WAS LAST SEEN ON (B)(6) 2011 AND WAS DOING WELL. 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
    95168 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317050

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other SOLYX SIS SYSTEM