BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 1913112 · Received December 2, 2010

    Report

    Report Number
    3005099803-2010-04936
    Event Type
    Injury
    Date Received
    December 2, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    'DESCRIBE EVENT OR PROBLEM' AND 'OTHER RELEVANT HISTORY' HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: ALTHOUGH THE PATIENT'S EXACT AGE IS UNKNOWN, SHE IS REPORTED TO BE OVER 18 YEARS OF AGE. DEVICE EXPIRATION DATE: ALTHOUGH THE LOT# OF THE DEVICE IS UNKNOWN, THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; 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 FOLLOWING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE PERFORMED BETWEEN (B)(6) AND (B)(6) 2010 (EXACT PROCEDURE DATE UNKNOWN), THE PATIENT WAS FOUND TO HAVE PRESENTED WITH MESH EROSION AT A FOLLOW-UP VISIT DURING THE WEEK OF (B)(6) 2010 (EXACT DATE OF VISIT UNKNOWN). THE LOCATION OF THE EROSION WAS REPORTED TO BE AT THE INCISION SITE. WHILE THE PATIENT IS REPORTEDLY "DOING WELL," IT IS UNKNOWN WHAT INTERVENTION, IF ANY, WAS PERFORMED BY THE PHYSICIAN TO TREAT THE PATIENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PINNACLE ANTERIOR/APICAL MESH WAS IMPLANTED USING A HORIZONTAL INCISION. THE PHYSICIAN REPORTEDLY "EXCISED A SMALL PIECE OF THE MESH", AND THE PATIENT WAS PRESCRIBED PROGESTERONE CREAM (TYPE AND PRESCRIPTION DURATION UNKNOWN). NO FURTHER INTERVENTION IS PLANNED BY THE PHYSICIAN. THE COMPLAINANT INDICATED THAT THE PHYSICIAN DOES NOT BELIEVE THE DEVICE HAD ANY RELATION TO THE PROBLEM.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R