BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE ? MRI

    MDR report key: 21878345 · Received April 21, 2025

    Report

    Report Number
    3006630150-2025-02671
    Event Type
    Injury
    Date Received
    April 21, 2025
    Date of Event
    March 31, 2025
    Report Date
    April 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729907114
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 5110757. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 5103266. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF FROM THE SPINAL CORD STIMULATOR (SCS) DEVICE. THE PATIENT UNDERWENT AN SCS EXPLANT PROCEDURE WHERE IN ALL DEVICES WERE REMOVED. THE EXPLANTED DEVICE WILL NOT BE RETURN DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239313 PRECISION MONTAGE ? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1210B 352903 08714729907114

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention