BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 18447572 · Received January 4, 2024

    Report

    Report Number
    3006630150-2023-08388
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    December 12, 2023
    Report Date
    January 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: 7222778.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE PAIN DURING TRIAL PROCEDURE UPON EPIDURAL INSERTION. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE DEVICE WILL NOT BE RETURNED DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575162 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7216697 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention