BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 18616535 · Received January 31, 2024

    Report

    Report Number
    3006630150-2024-00377
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    April 27, 2021
    Report Date
    January 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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-MRI. UPN: M365SC2408740. MODEL: SC-2408-74. SERIAL: (B)(6).. BATCH: 7070971/7071059.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS NOT RECEIVED ADEQUATE PAIN RELIEF DESPITE MULTIPLE REPROGRAMMING. LEAD MIGRATION WAS CONFIRMED THROUGH FLUOROSCOPY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WERE KEPT BY THE FACILITY AND WAS DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074776 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 369447 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention