BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 2880236 · Received December 19, 2012

    Report

    Report Number
    3005099803-2012-06110
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT# 3005099803-2012-06109 FOR A DESCRIPTION OF THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE ANTERIOR APICAL PELVIC FLOOR REPAIR KIT WAS IMPLANTED ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED URINARY RETENTION, FREQUENCY, VAGINAL SCARRING, NOCTURIA, RECURRENT URINARY TRACT INFECTIONS, DYSPAREUNIA, VAGINAL PAIN, WORSENING INCONTINENCE AND PELVIC PAIN. ALL OTHER INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317050 0ML9040901

    Patients

    Seq Age Sex Outcome Treatment
    1 Other OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM