BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 10394248 · Received August 11, 2020

    Report

    Report Number
    3006630150-2020-03373
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    February 25, 2020
    Report Date
    August 11, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 5130459. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 5137189. PRODUCT FAMILY: SCS-EXTENSION, UPN: (B)(4), MODEL: SC-3138-25, SERIAL: (B)(4), BATCH: 7034049. PRODUCT FAMILY: SCS-EXTENSION, UPN: (B)(4), MODEL: SC-3138-25, SERIAL: (B)(4), BATCH: 7021614.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A FULL SYSTEM EXPLANT TO REMOVE THE IPG, LEADS AND EXTENSIONS DUE TO AN INFECTION. THE PATIENT WAS DOING WELL POST OPERATIVELY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN FURTHER INFORMATION IN REGARD TO ANY ADDITIONAL INTERVENTION ADMINISTERED FOR PATIENTS INFECTION, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858102 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 357111 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention