BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 8248401 · Received January 15, 2019

    Report

    Report Number
    3005099803-2019-00096
    Event Type
    Injury
    Date Received
    January 15, 2019
    Date of Event
    December 18, 2018
    Report Date
    January 15, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INFORMATION ABOUT THE EVENT DATE, THEREFORE THE BSC AWARE DATE WAS USED. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. ADDITIONAL CONTACTS: DR. (B)(6). LITERATURE: BIENIEK JM, HOLSTE TL, PLATTE RO, MINASSIAN VA (2012) CYSTOSCOPIC REMOVAL OF INTRAVESICAL SYNTHETIC MESH EXTRUSION WITH THE AID OF ENDOLOOP SUTURES AND ENDOSCOPIC SCISSORS. INT UROGYNECOL J (2012) 23: 1137-1139. DOI: 10.1007/S00192-012-1668-4. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT 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 LYNX SYSTEM WAS IMPLANTED DURING A MIDURETHRAL SLING PLACEMENT PROCEDURE PERFORMED FOUR YEARS PRIOR TO HER PRESENTATION IN THE COMPLAINANT'S OFFICE FOR A SECOND OPINION. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED POST-OPERATIVE URINARY URGENCY, FREQUENCY, SUPRAPUBIC PAIN, AND RECURRENT URINARY TRACT INFECTIONS. SHE SUBSEQUENTLY UNDERWENT PLACEMENT OF A SACRAL NEUROSTIMULATOR FOR PRESUMED REFRACTORY OVERACTIVE BLADDER. THE PATIENT CONTINUED TO SUFFER FROM SIMILAR SYMPTOMS AND PRESENTED TO THE COMPLAINANT'S OFFICE FOR A SECOND OPINION. SUBSEQUENTLY, CYSTOSCOPY REVEALED A 2CM MESH EXTRUSION IN THE POSTERIOR BLADDER WALL NEAR THE RIGHT URETERAL ORIFICE. THIS INTRAVESICAL MESH EXTRUSION WAS TREATED VIA OPERATIVE CYSTOSCOPY. A VICRYL ENDOLOOP SUTURE WAS INTRODUCED INTO THE BLADDER ADJACENT TO THE CYSTOSCOPE AND PASSED UNDER THE BAND OF MESH. THE DISTAL LOOP OF SUTURE WAS GRIPPED WITH GRASPERS AND CLAMPED OUTSIDE THE URETHRA FOR TRACTION. THEY THEN INTRODUCED 5MM ENDOSCOPIC SCISSORS THROUGH THE WORKING CHANNEL OF THE CYSTOSCOPE TO CUT THE LEFT INSERTION OF THE MESH INTO THE MUCOSA. A SECOND ENDOLOOP SUTURE WAS NEXT SECURED AROUND THE REMAINING PORTION OF THE MESH AND SCISSORS USED TO EXCISE THE RIGHT EXIT SITE OF MESH. REMAINING MESH FIBERS WERE TRIMMED UNTIL NO FIBERS WERE SEEN. FOLLOW-UP CYSTOSCOPIC EXAM AT 3 MONTHS DEMONSTRATED NECROTIC DEBRIS AT ONE OF THE MESH EXIT SITES AND TWO MINISCULE FIBERS NEAR THE OTHER PREVIOUS MESH EXIT SITE. HER SYMPTOMS HAD COMPLETELY RESOLVED OTHER THAN MILD URINARY URGENCY WHICH IS REPORTEDLY BEING MANAGED CONSERVATIVELY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41069 LYNX SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention