BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 20377496 · Received October 4, 2024

    Report

    Report Number
    3006630150-2024-06693
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    January 1, 2021
    Report Date
    October 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    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

    BLOCK B3: APPROXIMATED BASED ON THE INFORMATION PROVIDED BY THE PATIENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: N/A. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 5155072. BRAND NAME: PRECISION SPECTRA. UPN: M365SC11320. MODEL: SC-1132. SERIAL: (B)(6). BATCH: 202893.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNCOMFORTABLE SENSATION FROM THE PARIETAL LEAD AND LEAD EXTENSION OF THE SPINAL CORD STIMULATOR (SCS), THEREFORE THE DEVICE WAS NOT BEING USED FOR STIMULATION. IT WAS ALSO STATED THAT THE PATIENT LOST WEIGHT AND THE IMPLANTABLE PULSE GENERATOR (IPG) TILTED IN AN ANGLE IN THE POCKET. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE LEAD AND LEAD EXTENSION WERE CUT AND EXPLANTED, AND THE IPG WAS SLIGHTLY REPOSITIONED IN THE AXILLA AREA. THE PATIENT IS DOING WELL POST OPERATIVELY. THE LEAD AND LEAD EXTENSION WERE DISCARDED AND THE IPG REMAINS IMPLANTED, THEREFORE NO DEVICES WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693318 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 5098519 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention