BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 12924481 · Received December 3, 2021

    Report

    Report Number
    3005099803-2021-06433
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    June 10, 2016
    Report Date
    December 3, 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 A LYNX IMPLANT WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2016. THE PATIENT EXPERIENCED COMPLICATIONS, FURTHER SURGERY, AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: EEP; BACK PAIN; VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; ANAL PAIN; RECT PAIN; THI PAIN; PAIN INTER; DIFF BOWEL; INCONT NOT PRES; REC INCONT; AGGRAV INCONT; DAMAGE; PSYCH. SURGICAL INTERVENTIONS: ON (B)(6) 2016 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE LYNX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: URETHRAL SYNTHETIC SLING DIVISION, ANTERIOR VAGINAL COMPARTMENT REPAIR AND CYSTOSCOPY. ON (B)(6) 2016 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE LYNX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: BULKAMID URETHRAL BULKING SYSTEM. ON (B)(6) 2016 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE LYNX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: ANTERIOR VAGINAL COMPARTMENT REPAIR, URETHROVAGINAL FISTULA CLOSURE, BLADDER STRESS INCONTINENCE SLING PROCEDURE. ON (B)(6) 2017 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE LYNX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: URETHROSCOPY. ON (B)(6) 2017 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE LYNX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: CYSTOSCOPY URETHRAL SYNTHETIC SLING DIVISION, ANTERIOR VAGINAL COMPARTMENT REPAIR, URETHROPLASTY SINGLE STAGE REPAIR. ON (B)(6) 2017 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE LYNX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: CYSTOSCOPY. ON (B)(6) 2017 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE LYNX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: CYSTOSCOPY. ON (B)(6) 2019 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE LYNX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: CYSTOSCOPY. ON (B)(6) 2019 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE LYNX IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: URETHRAL DIVERTICULUM EXCISION, CERVIX CAUTERISATION, URETHROPLASTY SINGLE STAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825170 LYNX SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION 850-300

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention