BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 16522794 · Received March 10, 2023

    Report

    Report Number
    3006630150-2023-01196
    Event Type
    Injury
    Date Received
    March 10, 2023
    Date of Event
    February 15, 2023
    Report Date
    March 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC231650E0. MODEL: SC-2316-50E. SERIAL: (B)(4). BATCH: 7153608.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMMEDIATELY FOLLOWING THE PATIENT'S SPINAL CORD STIMULATION (SCS) TRIAL PROCEDURE, THE PATIENT EXPERIENCED BACK AND ABDOMINAL PAIN. THREE HOURS AFTER THE TRIAL PROCEDURE, THE PATIENT EXPERIENCED PARALYSIS FROM THE WAIST DOWN. THE PATIENT WAS ADMINISTERED INTRAVENOUS (IV) TORADOL. THE PHYSICIAN ASSESSED THAT THE PATIENT CONTINUED TO TAKE ASPIRIN PRIOR TO THE TRIAL PERIOD. THE LEADS WERE DISCARDED FOLLOWING THEIR EXPLANT TO DECOMPRESS THE HEMATOMA IN THE PATIENT'S NINTH THORACIC VERTEBRA. THE PATIENT REMAINS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141788 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7152472 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization| S