BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 19265653 · Received May 7, 2024

    Report

    Report Number
    3006630150-2024-02948
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    May 9, 2018
    Report Date
    May 7, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: M365SC2408560 MODEL: SC-2408-56 SERIAL: (B)(6) BATCH: 21576575. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: M365SC2408560 MODEL: SC-2408-56 SERIAL: (B)(6) BATCH: 21576575.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVE SUFFICIENT PAIN RELIEF. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED. POST OPERATIVELY, THE PATIENT WAS NOTED TO HAVE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99557 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 21347832 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention