BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 11345998 · Received February 18, 2021

    Report

    Report Number
    3005099803-2021-00353
    Event Type
    Injury
    Date Received
    February 18, 2021
    Date of Event
    June 21, 2013
    Report Date
    March 14, 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) 2013, IMPLANT DATE, AS NO EVENT DATE WAS REPORTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANT SURGEON IS: DR. (B)(6). GENERAL PRACTITIONER: DR. (B)(6). BLOCK H6: IMDRF PATIENT CODE E1309, E2401 AND E1405 CAPTURE THE REPORTABLE EVENTS OF URINARY RETENTION, INJURY AND DYSPAREUNIA.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BOSTON SCIENTIFIC ADVANTAGE DEVICE WAS IMPLANTED INTO THE PATIENT DURING AN ANTERIOR VAGINAL REPAIR TVT + CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2013 DUE TO INCONTINENCE. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THE SECOND ADVANTAGE DEVICE AFTER THE IMPLANTATION OF THE FIRST ADVANTAGE DEVICE ON (B)(6) 2010. ON (B)(6) 2013, THE PATIENT STRESS INCONTINENCE HAD RESOLVED AND HER URGENCY WAS IMPROVED. ANATOMICALLY ALL WAS FINE THOUGH A COUPLE OF LONGER LASTING PDS SUTURES HAD TO BE DIVIDED. THE PATIENT SHOULD BE MORE SEXUALLY COMFORTABLE. RESIDUAL IS UP SLIGHTLY AT 75 ML. ON (B)(6) 2014, THE PATIENT WAS STILL HAVING URGENCY AND AN OVERSENSITIVE AND OVERACTIVE BLADDER WITH A DEGREE OF VOIDING DYSFUNCTION, BUT THE RESIDUAL WAS DOWN TO 33 ML FROM 75 MLS. ON (B)(6) 2014, URODYNAMICS SHOWED EVIDENCE OF POSTURE UNSTABLE DETRUSOR FUNCTION. THE URETHRA LOOKED PARTICULARLY NARROW. THE RECOMMENDED INTERVENTION WAS NEUROMODULATION. CYSTOSCOPY REVEALED NORMAL URETHRA, NORMAL BLADDER, NO EROSION, AND SCARRING AT THE DOME FROM PREVIOUS SPC (SUPRAPUBIC CATHETER).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2013, IMPLANT DATE, AS NO EVENT DATE WAS REPORTED. THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANT SURGEON IS: DR.(B)(6). (B)(4). THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION; 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 A BOSTON SCIENTIFIC ADVANTAGE DEVICE WAS IMPLANTED INTO THE PATIENT DURING A REVISION PROLAPSE AND CONTINENCE SURGERY PERFORMED ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THE SECOND ADVANTAGE DEVICE AFTER THE IMPLANTATION OF THE FIRST ADVANTAGE DEVICE ON (B)(6) 2010. ON (B)(6) 2013, THE PATIENT STRESS INCONTINENCE HAD RESOLVED AND HER URGENCY WAS IMPROVED. ANATOMICALLY ALL WAS FINE THOUGH A COUPLE OF LONGER LASTING PDS SUTURES HAD TO BE DIVIDED. THE PATIENT SHOULD BE MORE SEXUALLY COMFORTABLE. RESIDUAL IS UP SLIGHTLY AT 75 ML. ON (B)(6) 2014, THE PATIENT WAS STILL HAVING URGENCY AND AN OVERSENSITIVE AND OVERACTIVE BLADDER WITH A DEGREE OF VOIDING DYSFUNCTION, BUT THE RESIDUAL WAS DOWN TO 33 ML FROM 75 MLS. ON (B)(6) 2014, URODYNAMICS SHOWED EVIDENCE OF POSTURE UNSTABLE DETRUSOR FUNCTION. THE URETHRA LOOKED PARTICULARLY NARROW. THE RECOMMENDED INTERVENTION WAS NEUROMODULATION. CYSTOSCOPY REVEALED NORMAL URETHRA, NORMAL BLADDER, NO EROSION, AND SCARRING AT THE DOME FROM PREVIOUS SPC (SUPRAPUBIC CATHETER). 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
    241943 ADVANTAGE SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068502000 ML00001152 08714729470274

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention