BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM - HALO

    MDR report key: 9258502 · Received October 30, 2019

    Report

    Report Number
    3005099803-2019-05223
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    December 12, 2017
    Report Date
    October 30, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729718987
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: OTHER: HC ADVERSE INCIDENT REPORT REFERENCE (B)(4); SUBMITTED TO HC (HEALTH CANADA) BY THE PATIENT. 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 SYSTEM - HALO WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017, THE PATIENT BEGAN EXPERIENCING SIGNIFICANT PAIN IN THE BUTTOCKS, HIPS, LEGS, AND LOWER BACK, AND DURING AND AFTER SEXUAL INTERCOURSE. AT TIMES, SHE HAS SLIGHT PAIN IN THE GROIN AND VAGINA. SHE ALSO HAS NOCTURNAL PAIN WHEN IN SUPINE POSITION AND FREQUENT AWAKENINGS. AS A RESULT, THERE HAS BEEN A DECREASE IN THE FREQUENCY OF HER SEXUAL INTERCOURSE, IN THE LENGTH OF HER MARCHES AND IN HER SPEED OF PERFORMANCE, IN THE WEIGHT THAT SHE LIFTS, AND IN PARTICIPATION IN HER ACTIVITIES IN SOCIETY, FAMILY, DOMESTIC LIFE, AND AT WORK. SHE IS UNABLE TO SIT OR STAND FOR 45 MINUTES OR MORE WITHOUT INCREASING PAIN AND STIFFNESS. SHE CANNOT DO HER 35-HOURS-A-WEEK JOB AND SHE IS ON SICK LEAVE WITH REDUCED WORKLOAD TO 3 DAYS A WEEK, AND IF POSSIBLE, NOT ONLINE FOR 3 DAYS DUE TO INCREASED PAIN FOR SEVERAL DAYS. THE PATIENT WAS DIAGNOSED WITH MAJOR DEPRESSION AFTER 9 MONTHS OF ENDURANCE OF THESE CHRONIC PAIN THAT OCCURRED JUST AFTER THE IMPLANTATION AND ALSO BECAUSE OF THE DOCTORS' INABILITY TO FIND WHAT SHE HAD AND IT DISCOURAGED HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051140 OBTRYX SYSTEM - HALO MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068505000 0020825867 08714729718987

    Patients

    Seq Age Sex Outcome Treatment
    1 Other