BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 12930613 · Received December 4, 2021

    Report

    Report Number
    3005099803-2021-07021
    Event Type
    Injury
    Date Received
    December 4, 2021
    Date of Event
    September 10, 2019
    Report Date
    December 4, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE UPN PROVIDED WAS CHOSEN AS A REPRESENTATIVE UPN TO CAPTURE THE IMPLANTED DEVICE. 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 · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE WAS IMPLANTED ON (B)(6) 2017. THE PATIENT EXPERIENCED COMPLICATIONS, FURTHER SURGERY, AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: VAGINAL PAIN; PELVIC PAIN; PAINFUL INTERCOURSE; INABILITY TO HAVE INTERCOURSE; INCONTINENCE NOT PRESENT BEFORE IMPLANT; RECURRENT INCONTINENCE. SURGICAL INTERVENTIONS: ON (B)(6) 2017 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE ADVANTAGE IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: TVT ANTERIOR VAGINAL REPAIR. ON (B)(6) 2019 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE ADVANTAGE IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: CYSTOSCOPY AND URETHRAL DILATATION. ON (B)(6) 2020 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE ADVANTAGE IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: CYSTOSCOPY WITH URETHROSCOPY INSERTION OF SACRAL NEURO MODULATOR STAGE 1 AND STAGE 2. PLACEMENT OF SACRAL NERVE LEAD AND PULSE GENERATOR, SUBCUTANEOUS PLACEMENT OF SACRAL NERVE ELECTRODES. ON (B)(6) 2021 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE ADVANTAGE IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: REMOVAL OF SACRAL NEURO MODULATOR AND BROKEN SACRAL NERVE LEAD. NONSURGICAL TREATMENTS: ON (B)(6) 2021 THE PATIENT COMMENCED OTHER (PLEASE SPECIFY) FOR THE TREATMENT OF: TO FULLY EMPTY BLADDER TO STOP URINARY TRACT INFECTIONS, AND TO STO THE BLADDER OVERFILLING AND LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828751 ADVANTAGE SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION 850-200

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention