BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 2990078 · Received March 5, 2013

    Report

    Report Number
    3005099803-2013-01376
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    February 14, 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

    NOTE: THIS MFR REPORT PERTAINS TO THE FIRST OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT# 3005099803-2013-01377 AND 3005099803-2013-01378 FOR A DESCRIPTION OF THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT WAS IMPLANTED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED PAIN, SUFFERING, DISABILITY, IMPAIRMENT, AND THE INABILITY TO ENGAGE IN CHOSEN AND NECESSARY ACTIVITIES. ACCORDING TO THE PHYSICIAN, NO PATIENT COMPLICATIONS WERE REPORTED FOLLOWING THE PROCEDURE. THE PATIENT RETURNED TO THE PHYSICIAN'S OFFICE TWICE, WITH THE MOST RECENT APPOINTMENT ON (B)(6) 2011. NO PATIENT COMPLAINTS OR SUBJECTIVE FINDINGS WERE REPORTED. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94069 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317100 1ML0062105

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UPHOLD VAGINAL SUPPORT SYSTEM| SOLYX SINGLE INCISION SLING SYSTEM