BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 11757628 · Received April 30, 2021

    Report

    Report Number
    3006630150-2021-01879
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    April 3, 2021
    Report Date
    April 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: 7071219.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND DEHISCENCE CAUSED BY BEING TOO ACTIVE AFTER THE IMPLANT PROCEDURE. SYMPTOM OF REDNESS WAS NOTED AT THE POCKET SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE NOR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICES WERE REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648339 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 374786 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention