BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 3083384 · Received April 29, 2013

    Report

    Report Number
    3005099803-2013-03260
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH A PINNACLE PELVIC FLOOR REPAIR KIT (EXACT TYPE UNKNOWN) SOMETIME IN 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT NOW EXPERIENCES PELVIC PAIN AND MESH EROSION WITH UTERUS IN-SITU, AND DESIRES SURGICAL MANAGEMENT. REPORTEDLY, THE PATIENT IS OR WAS INTENDED TO UNDERGO A VAGINAL MESH REMOVAL WITH ANTERIOR COLPORRHAPHY AND CYSTOSCOPY. ALL OTHER INFORMATION IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH THE UNSPECIFIED PINNACLE PELVIC FLOOR REPAIR KIT DURING A SACROSPINOUS LIGAMENT FIXATION WITH TVT PROCEDURE ON (B)(6) 2009. ON (B)(6) 2010 THE PATIENT WAS EVALUATED IN THE EMERGENCY ROOM (SPECIFICS UNKNOWN) BUT WAS NOT ADMITTED. THE EVALUATION REVEALED BULGING AND EXPOSED MESH, AND A CORRECTIVE OUTPATIENT SURGERY WAS PERFORMED (DETAILS UNKNOWN) ON (B)(6) 2010. THE POST-OPERATIVE OUTCOME IS UNKNOWN, BUT THE MESH WAS EXPLANTED ON (B)(6) 2013. THE PATIENT WAS LAST SEEN ON (B)(6) 2013 AND WAS REPORTEDLY FEELING GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184968 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK558

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R