BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 16546238 · Received March 15, 2023

    Report

    Report Number
    3006630150-2023-01264
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    March 10, 2023
    Report Date
    March 15, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797821
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: INFINION 16. UPN: M365SC2316700. MODEL: SC-2316-70. SERIAL: (B)(4). BATCH: 7081064.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT BECAME INFECTED WITH PNEUMONIA PARTIALLY THROUGH THE TRIAL LEAD TESTING PERIOD. THE PATIENT UNDERWENT AN EARLY LEAD PULL PROCEDURE DUE TO THE INFECTION AND WAS EXPECTED TO FULLY RECOVER. THE INFECTION WAS ASSESSED AS NOT DEVICE RELATED. THE LEADS WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036668 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70 7081061 08714729797821

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention