BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 18576312 · Received January 24, 2024

    Report

    Report Number
    3006630150-2024-00222
    Event Type
    Injury
    Date Received
    January 24, 2024
    Date of Event
    January 4, 2024
    Report Date
    January 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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: 7230942

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT HAD MID BACK PAIN, DISCOMFORT, HEADACHE AND DIZZINESS. THE X-RAY IMAGES DID NOT SHOW ANY REASON WHY THE LEADS COULD CAUSE THE DISCOMFORT. THE PATIENT HAD A LEAD PULL AND THE PATIENT WAS DOING WELL. THE EXPLANTED LEADS WERE DISCARDED BY THE FACILITY. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056745 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7224337 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention