BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 19757653 · Received July 16, 2024

    Report

    Report Number
    3006630150-2024-04596
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    June 18, 2024
    Report Date
    July 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    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 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7079404. BRAND NAME: LINEAR 3-6, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 7073805. BRAND NAME: LINEAR 3-6, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 7073649.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOUR SPINAL CORD STIMULATION LEADS MIGRATED WITHIN THE PATIENT. THE PHYSICIAN NOTED THAT THE PATIENT DID NOT FOLLOW HIS ACTIVITY RESTRICTION INSTRUCTIONS POSTOPERATIVELY. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THREE LEADS WERE EXPLANTED AND REPLACED, AND LEAD SC-2366-50, SN (B)(6) WAS REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE LEADS WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715279 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 7079860 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention