BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 21912040 · Received April 25, 2025

    Report

    Report Number
    3006630150-2025-02794
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    January 16, 2025
    Report Date
    April 23, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCKS B3 AND H6. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352700 MODEL: SC-2352-70 SERIAL: (B)(6). BATCH: 7073265/7073000 UDI: (B)(4).

    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: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2352700; MODEL: SC-2352-70; SERIAL: (B)(6); BATCH: 7073265/7073000; UDI: (B)(4); UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS NOTING 0% RELIEF AND PATIENT ALSO REPORTS HIS BATTERY IS NO LONGER HOLDING A CHARGE. TYLENOL # 4 WAS NOT HELPING HIS PAIN ANYMORE. C ARM IMAGING CONFIRMED SPINAL CORD STIMULATION (SCS) LEADS HAVE MIGRATED. THE PATIENT UNDERWENT REVISION PROCEDURE. PATIENT IS DOING WELL POST OP. NO DEVICES WILL BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NO RELIEF. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WOULD NO LONGER HOLD A CHARGE. IMAGING CONFIRMED SPINAL CORD STIMULATION (SCS) LEADS HAD MIGRATED. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WLLL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539335 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 375508 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1