BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? PRO

    MDR report key: 22014989 · Received May 13, 2025

    Report

    Report Number
    3006630150-2025-03311
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    April 18, 2025
    Report Date
    May 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    00191506018726
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2318500, MODEL: SC-1232, SERIAL: (B)(6), BATCH: 5001118, UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12320, MODEL: SC-4316, SERIAL: (B)(6), BATCH: 755073, UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, BATCH: 33872611, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD HAD MIGRATED. THE PATIENT UNDERWENT EXPLANT PROCEDURE. DURING THE PROCEDURE ON REMOVAL OF THE LEFT LEAD PHYSICIAN INCURRED WHAT HE THINKS IS A DURAL TEAR AND THERE WAS SOME CEREBROSPINAL FLUID (CSF) LOSS. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968798 INFINION? PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2318-50 5001042 00191506018726

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention