BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 1904003 · Received November 20, 2010

    Report

    Report Number
    3005099803-2010-04889
    Event Type
    Injury
    Date Received
    November 20, 2010
    Report Date
    October 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, THE PATIENT'S AGE HAS BEEN REPORTED AS OVER EIGHTEEN YEARS OLD. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN IMPLANTED AND WILL NOT BE RETURNED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ANTERIOR REPAIR SINGLE INCISION SLING AND POSTERIOR REPAIR PROCEDURE WAS PERFORMED (DATE UNKNOWN), USING AN ELEVATE MESH (AMERICAN MEDICAL SYSTEMS INC), MINIARC SLING (AMERICAN MEDICAL SYSTEMS INC) AND PINNACLE POSTERIOR PFR KIT (BOSTON SCIENTIFIC CORPORATION). POST PROCEDURE, THE PATIENT REPORTED SLIGHT RECTAL PAIN AND DISCHARGE OF A LITTLE BLOOD AND PUS FROM HER VAGINA. THE CAUSE OF THE DISCHARGE IS UNKNOWN. THE PHYSICIAN OPINED, HE "MAY HAVE PUT THE PINNACLE MESH IN TOO TIGHT". NO FURTHER INFORMATION REGARDING THE PATIENT'S CONDITION OR FURTHER MEDICAL INTERVENTION HAS BEEN FORTHCOMING; ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MINIARC SLING - ANTERIOR REPAIR| ELEVATE MESH - ANTERIOR REPAIR