BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION PRO

    MDR report key: 20489968 · Received October 20, 2024

    Report

    Report Number
    3006630150-2024-07145
    Event Type
    Injury
    Date Received
    October 20, 2024
    Date of Event
    September 24, 2024
    Report Date
    November 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    00191506018726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12320, MODEL: SC-1232, SERIAL: (B)(6), BATCH: 561247.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2318500; MODEL: SC-2318-50; SERIAL: (B)(6); BATCH: 5000992.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NEW PAIN AT THE LOWER LEFT LEG FOLLOWING A SPINAL CORD STIMULATION (SCS) LEAD REPLACEMENT PROCEDURE (MFR: 3006630150-2024-06891). THE PHYSICIAN BELIEVES THAT THE EPIDURAL SPACE DOES NOT HAVE ENOUGH ROOM AND MAY BE CAUSING THE PAIN. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL DEVICES WERE EXPLANTED. THE EXPLANTED DEVICES WERE DISPOSED BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NEW PAIN AT THE LOWER LEFT LEG FOLLOWING A SPINAL CORD STIMULATION (SCS) LEAD REPLACEMENT PROCEDURE (MFR - 3006630150-2024-06891). THE PHYSICIAN BELIEVES THAT THE EPIDURAL SPACE DOES NOT HAVE ENOUGH ROOM AND MAY BE CAUSING THE PAIN. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077461 INFINION PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2318-50 5000983 00191506018726

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention