BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 16500610 · Received March 8, 2023

    Report

    Report Number
    3006630150-2023-01107
    Event Type
    Injury
    Date Received
    March 8, 2023
    Date of Event
    February 16, 2023
    Report Date
    March 8, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216700, MODEL: SC-8216-70, SERIAL: (B)(4), BATCH: 7073273.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT DID NOT FOLLOW POST INSTRUCTIONS AND THE LEAD MIGRATED WHICH CAUSED INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727692 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 376760 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention