BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 15995047 · Received December 16, 2022

    Report

    Report Number
    3005099803-2022-07461
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    August 23, 2017
    Report Date
    December 16, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729784777
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS APPROXIMATED TO (B)(6) 2017, FIRST REVISION DATE, AS NO EVENT DATE WAS REPORTED. THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANTING AND REVISION SURGEON IS (B)(6). (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM WAS USED DURING AN ANTERIOR AND POSTERIOR REPAIR, SACROSPINOUS HYSTEROPEXY, MID-URETHRAL SLING AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2017, FOR THE TREATMENT OF RECURRENT PROLAPSE AND STRESS URINARY INCONTINENCE. FINDING OF THE PROCEDURE INCLUDES ABSENCE OF LABIA MINORA AND MAJORA CONSISTENT WITH RADICAL VULVECTOMY. ON(B)(6) 2017, THE PATIENT UNDERWENT SLING LOOSENING AND CYSTOSCOPY WITH BLADDER BIOPSY WITH INDICATION OF OBSTRUCTED VOIDING AND TRIGONE LESION REMOVAL.. A GENTAMICIN WAS GIVEN INTRA-OPERATION DUE TO URINARY TRACT INFECTION. ON (B)(6) 2018, PATIENT UNDERWENT SLING DIVISION AND PARTIAL EXCISION AND CYSTOSCOPY WITH URETHRAL DILATION DUE TO URINARY OBSTRUCTION POST MID-URETHRA SLING AND SEVERE OVERACTIVE BLADDER. ON (B)(6) 2018, PATIENT UNDERWENT FLUOROSCOPIC PLACEMENT OF S3 LEAD FOR STAGE 1 SACRAL NEUROMODULATION. OPERATIVE FINDING INCLUDES OVERACTIVE BLADDER AND FECAL INCONTINENCE. ON (B)(6) 2018, THE PATIENT UNDERWENT IMPLANTATION OF PULSE GENERATOR FROM AN UNKNOWN MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484329 ADVANTAGE FIT SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068502110 0000060408 08714729784777

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention