BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 22200754 · Received June 13, 2025

    Report

    Report Number
    3006630150-2025-04390
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    March 17, 2025
    Report Date
    June 13, 2025
    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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 5041935. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 5041602. UDI:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED FREQUENT AND EXTENDED IMPLANTABLE PULSE GENERATOR (IPG) CHARGING DESPITE TROUBLESHOOTING ATTEMPTS. ADDITIONALLY, THE LEADS EXHIBITED ABNORMAL IMPEDANCES AND PATIENT LOST PAIN RELIEF. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE COMPONENTS WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375865 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 352911 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention