BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 18438942 · Received January 3, 2024

    Report

    Report Number
    3006630150-2023-08334
    Event Type
    Injury
    Date Received
    January 3, 2024
    Date of Event
    December 8, 2023
    Report Date
    January 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: M365SC231650E, MODEL: SC-2316-50E, SERIAL: (B)(6), BATCH: 7223454.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD MIDTRIAL REPROGRAMMING, BUT PATIENT SCRATCHED ALMOST ALL OF THE TEGADERM AND TAPE OFF HER BACK EXPOSING HER TRIAL LEADS. THE PATIENT UNDERWENT LEAD PULL PROCEDURE, AND THE EXPLANTED LEADS WERE NOT RETURN AS IT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587946 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7223773 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention