BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 16594859 · Received March 22, 2023

    Report

    Report Number
    3006630150-2023-01474
    Event Type
    Injury
    Date Received
    March 22, 2023
    Date of Event
    July 29, 2022
    Report Date
    March 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-4, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7072645. BRAND NAME: LINEAR 3-4, UPN: (B)(4), MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 7072845, BRAND NAME: LINEAR 3-4, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7071024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A DEEP BRAIN STIMULATION IMPLANT PROCEDURE, THE PATIENT DID NOT RECEIVE THE EXPECTED PAIN COVERAGE ON THE RIGHT SIDE. THE DEVICE WAS REPROGRAMMED, HOWEVER, THE EVENT DID NOT RESOLVE. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE TWO OF THE FOUR IMPLANTED LEADS WERE REPLACED PER THE PHYSICIANS PREFERENCE; THERE WERE NO ISSUES WITH THE LEADS. 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
    1103552 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 7073373 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention