BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 11135407 · Received January 7, 2021

    Report

    Report Number
    3005099803-2021-00005
    Event Type
    Injury
    Date Received
    January 7, 2021
    Date of Event
    May 24, 2011
    Report Date
    March 8, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729470274
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3 (DATE OF EVENT): DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2011 (IMPLANT DATE) AS NO EVENT DATE WAS REPORTED. BLOCK E1: THIS COMPLAINT WAS REPORTED BY THE PATIENT'S LAWYER. THE DEVICE WAS IMPLANTED AT THE EASTERN SUBURBS PRIVATE HOSPITAL, RANDWICK. NSW, AUSTRALIA BY DR. RICHARD REID. BLOCK H6: PATIENT CODE 2348 CAPTURES THE REPORTABLE EVENT OF UNSPECIFIED INJURY. CONCLUSION CODE 4316 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR DEVICE NOT RETURNED. BLOCK H10: THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. BLOCK H11: BLOCKS B7, G2 AND H7 HAVE BEEN CORRECTED. BLOCKS B5, E1, E4, H6 AND H10 HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 10, 2023. BLOCK E1: THIS COMPLAINT WAS RECEIVED AS LITIGATION FROM A LEGAL SOURCE IN AUSTRALIA. THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANT SURGEON IS: DR. RICHARD REID THE EASTERN SUBURBS PRIVATE HOSPITAL 8 CHAPEL STREET RANDWICK NSW 2031 AUSTRALIA +011(612)93980800 BLOCK H6: PATIENT CODE E2401 CAPTURES THE REPORTABLE EVENT OF UNKNOWN INJURY. IMPACT CODE F12 HAS BEEN USED IN THE LIGHT OF THIS PATIENT SEEKING LEGAL RECOURSE FOR AN UNSPECIFIED PERSONAL INJURY RELATED TO THE DEVICE.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED FOR THE SAME PATIENT. REFER TO MANUFACTURER REPORT # 3005099803-2020-06622 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM WAS IMPLANTED ON (B)(4) 2011. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 10, 2023: THE PROCEDURES PERFORMED ON (B)(6) 2011 WERE ADVANTAGE TAPE IMPLANT, SMALL ANTERIOR REPAIR, AND CYSTOSCOPY + SPC TO TREAT A PATIENT WITH INTRACTABLE STRESS URINARY INCONTINENCE AND MESH EROSION. THE REVISION PROCEDURE PERFORMED IN (B)(6) 2011 INCLUDED A SMALL ANTERIOR EXPOSURE REPAIR FOR THE EXCISION OF THE EXPOSED MESH WHICH THE PHYSICIAN CONFIRMED TO HAVE ERODED AT THE APEX. THE ERODED MESH WAS EXCISED LOCALLY AND THE DEFECT WAS CLOSED WITH SUTURES. DURING THE ADVANTAGE IMPLANT, THE PHYSICIAN NOTED AN ADHERENT BLADDER ON THE PATIENT'S LEFT SIDE. THE PHYSICIAN PASSED THE NEEDLE MORE MEDIALLY TO AVOID THE ADHESION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AT THE CONCLUSION OF THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2011 (IMPLANT DATE) AS NO EVENT DATE WAS REPORTED. (B)(6). (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM WAS IMPLANTED ON (B)(6) 2011. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26791 ADVANTAGE SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068502000 1ML0102002 08714729470274

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other