BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX II SYSTEM - HALO

    MDR report key: 10892863 · Received November 24, 2020

    Report

    Report Number
    3005099803-2020-05649
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    May 31, 2017
    Report Date
    November 23, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729837565
    PMA / PMN Number
    K121754
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER: TGA DEVICE INCIDENT REPORT REFERENCE NO (B)(4); SUBMITTED TO TGA (THERAPEUTIC GOODS ADMINISTRATION) BY A HEALTHCARE PROFESSIONAL/USER. 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 AN OBTRYX II SYSTEM - HALO WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, FOLLOWING THE IMPLANTATION, THE PATIENT EXPERIENCED CHEST PAINS, HOSPITALIZATION, MULTIPLE PNEUMONIA AND PLEURISY (NO BACTERIA DETECTED), CHRONIC PRODUCTIVE COUGH LEADING TO UPPER RESPIRATORY DYSFUNCTION, CHRONIC BACK AND BUTTOCKS PAIN AND BLADDER LEAKAGE WHILE WALKING. THE PATIENT ALSO EXPERIENCED AUTOIMMUNE SYMPTOMS INCLUDING CHRONIC FATIGUE, JOINT PAIN AND STIFFNESS, VISION DISTURBANCE, MEMORY LOSS, HEADACHES, AND PASSING OUT. THE PATIENT INITIALLY NEEDED TO REDUCE WORKING HOURS TO 3 HOURS A DAY BUT EVENTUALLY HAS TO PERMANENTLY LEAVE JOB. SUBSEQUENTLY, THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2018. 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
    1359240 OBTRYX II SYSTEM - HALO MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068505110 0000045394 08714729837565

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R