BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN MRI

    MDR report key: 8354077 · Received February 20, 2019

    Report

    Report Number
    3006630150-2019-00676
    Event Type
    Injury
    Date Received
    February 20, 2019
    Date of Event
    February 11, 2019
    Report Date
    February 21, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951131
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL NUMBER/CATALOG NUMBER: SC-3138-25. SERIAL NUMBER: (B)(4). BATCH/LOT NUMBER : 7032587/7034172. MODEL/CATALOG DESCRIPTION: LEAD EXTENSION KIT 25CM . THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT PATIENTS PADDLE SITE HAD NOTABLE PUS AND INFECTION PRESENT. PHYSICIAN CLEANED OUT THE INFECTED SITE AND REMOVED ALL COMPONENTS. PHYSICIAN DOES NOT BELIEVE THAT THE INFECTION IS DEVICE RELATED. HE BELIEVES IT MAY HAVE BEEN FROM DELAY OF BATTERY PLACEMENT APPROVAL FROM PATIENTS INSURANCE. PATIENT WAS DOING WELL POST OPERATIVELY AND WAS GIVEN ANTIBIOTICS TO TREAT INFECTION.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-3138-25, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7032587/7034172, MODEL/CATALOG DESCRIPTION: LEAD EXTENSION KIT 25 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENTS PADDLE SITE HAD NOTABLE PUS AND INFECTION PRESENT. PHYSICIAN CLEANED OUT THE INFECTED SITE AND REMOVED ALL COMPONENTS. PHYSICIAN DOES NOT BELIEVE THAT THE INFECTION IS DEVICE RELATED. HE BELIEVES IT MAY HAVE BEEN FROM DELAY OF BATTERY PLACEMENT APPROVAL FROM PATIENTS INSURANCE. PATIENT WAS DOING WELL POST OPERATIVELY AND WAS GIVEN ANTIBIOTICS TO TREAT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148672 ARTISAN MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8416-70 21403342 08714729951131

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention