BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 20007151 · Received August 20, 2024

    Report

    Report Number
    3006630150-2024-05452
    Event Type
    Injury
    Date Received
    August 20, 2024
    Date of Event
    July 18, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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)(6), BATCH: 7223100.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT FELT HER ARMS HEAVY DURING TRIAL PERIOD, SO THE PHYSICIAN DECIDED TO PULL THE TRIAL LEADS. PATIENT IS STILL CURRENTLY BEING TREATED AT THE HOSPITAL. THE PHYSICIAN WAS UNAWARE OF THE CAUSE OF THE ISSUES. THE EXPLANTED DEVICE WAS DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2372333 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7222847 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention