BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 17573709 · Received August 18, 2023

    Report

    Report Number
    3006630150-2023-04889
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    July 31, 2023
    Report Date
    August 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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: 7181540.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT EXPERIENCED NEW ONSET THROBBING PAIN IN THE HAND THAT CONTINUED. THE PHYSICIAN PRESCRIBED STEROID TO THE PATIENT WHICH HELP A BIT TO RELIEVE THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073766 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7180140 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention