BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 20928738 · Received December 13, 2024

    Report

    Report Number
    3006630150-2024-08729
    Event Type
    Injury
    Date Received
    December 13, 2024
    Date of Event
    November 22, 2024
    Report Date
    December 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 7080418.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEAD MIGRATED WHICH WAS CONFIRMED THROUGH IMAGING. THE PATIENT UNDERWENT A PROCEDURE WHERE THE INTENT WAS TO RE-POSITION THE LEAD INTO THE CORRECT POSITION, HOWEVER THE PHYSICIAN CUT THE LEAD AND THEREFORE ENDED UP REPLACING THE LEAD. POST OPERATIVELY, THE PATIENT WAS DOING WELL RECEIVING GOOD COVERAGE OF THEIR PAIN AREA. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY. IT IS UNKNOWN WHICH OF THE TWO IMPLANTED LEADS WAS THE ONE INVOLVED WITH THE EVENT AND WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805213 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2366-50 7080473 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention