BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 3052420 · Received April 11, 2013

    Report

    Report Number
    3005099803-2013-02136
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT WAS IMPLANTED (B)(6) 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN, THE PATIENT WAS SEEN (B)(6) 2009 AND PRESENTED DISRUPTION OF THE SUTURE LINE AT THE APEX ANTERIORLY FOLLOWING SEXUAL INTERCOURSE. THE PATIENT WAS SEEN AGAIN (B)(6) 2009 AND UNDERWENT A SECOND PROCEDURE TO FIX THE DISRUPTION. VISIBLE AND PALPABLE EXTRUDING MESH WAS TRIMMED AND THE DEFECT CLOSED. THE PATIENT WAS SEEN ON THREE POST-OPERATIVE VISITS AFTER (B)(6) 2009. THE FINAL POST-OPERATIVE VISIT WAS (B)(6) 2009 AND THE PATIENT PRESENTED NO EXPOSED MESH. APPROXIMATELY ONE YEAR LATER, THE PHYSICIAN RECEIVED A REQUEST TO TRANSFER THE PATIENT'S RECORDS TO A UROGYNECOLOGIST. 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
    155027 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention