BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 18245564 · Received December 1, 2023

    Report

    Report Number
    3006630150-2023-07489
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    November 3, 2023
    Report Date
    December 1, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2352500; MODEL: SC-2352-50; SERIAL:(B)(6); BATCH: 7072371. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI; UPN: M365SC12000; MODEL: SC-1200; SERIAL: (B)(6); BATCH: 373696.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED. THE PATIENT UNDERWENT A LEAD AND BATTERY REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451130 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 7072191 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention