BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 19953110 · Received August 9, 2024

    Report

    Report Number
    3006630150-2024-05234
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 16, 2024
    Report Date
    August 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789567
    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

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6. UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(6). BATCH: 7071194. BRAND NAME: LINEAR 3-6. UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(6). BATCH: 7070520. BRAND NAME: LINEAR 3-6. UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(6). BATCH: 7070887.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE PATIENTS' LEAD OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM MIGRATED CAUSING THE PATIENT TO EXPERIENCE INADEQUATE STIMULATION. IMAGING WAS PERFORMED WHICH CONFIRMED LEAD MIGRATION. THE PATIENT UNDERWENT A PROCEDURE IN WHICH ONE OF THE FOUR IMPLANTED LEADS WAS EXPLANTED AND REPLACED WITH A NEW LEAD, AND TWO OF THE LEADS WERE REPOSITIONED. THE PATIENT IS DOING WELL POST OPERATIVELY. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISPOSED OF BY THE FACILITY, AND THE REMAINING DEVICES REMAIN IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493435 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 7070103 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention