BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 19933886 · Received August 7, 2024

    Report

    Report Number
    3006630150-2024-05179
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    October 12, 2021
    Report Date
    August 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
    TN, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL: (B)(6). BATCH: 7071418/7071390.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN WHEN STIMULATION WAS TURNED ON AND HYPERSENSITIVITY AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535004 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 365249 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention