BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 16160397 · Received January 13, 2023

    Report

    Report Number
    3006630150-2023-00039
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    December 20, 2022
    Report Date
    January 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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: 7183515.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE PAIN AFTER THE TRIAL PROCEDURE. THE PATIENT UNDERWENT AN EARLY LEAD PULL PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED LEADS WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065444 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7183257 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention