BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 25065955 · Received May 4, 2026

    Report

    Report Number
    3006630150-2026-02853
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    November 12, 2024
    Report Date
    May 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED THE DAY THE SYSTEM WAS EXPLANTED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7080201 / 7080205. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318. BATCH/LOT NUMBER: 26090486. MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALL COMPONENTS WERE EXPLANTED AFTER PATIENT THOUGHT THAT THE DEVICE CAUSED HER TO FALL. THE EXPLANTED PRODUCTS WERE DISCARDED, AND PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413171 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 371082 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention