BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 15210613 · Received August 11, 2022

    Report

    Report Number
    3006630150-2022-03975
    Event Type
    Injury
    Date Received
    August 11, 2022
    Date of Event
    July 12, 2022
    Report Date
    August 11, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7071616. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 5058552.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE SPINAL CORD STIMULATION (SCS) SYSTEM. THE REASON FOR EXPLANT IS UNKNOWN HOWEVER, THERE WERE NO DEVICE ISSUES AS SPECIFIED BY THE DOCTOR. THE EXPLANTED DEVICES WERE NOT RETURNED FOR ANALYSIS, AS THEY WERE NOT RELEASED BY THE FACILITY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277490 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 365409 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention