BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISAN

    MDR report key: 15422880 · Received September 14, 2022

    Report

    Report Number
    3006630150-2022-04755
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    August 24, 2022
    Report Date
    November 4, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729779919
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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: M365SC8120700. MODEL: SC-8120-70. SERIAL: (B)(4). BATCH: 171568A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HEADACHES AND WAS ADMITTED TO THE HOSPITAL. A COMPUTED TOMOGRAPHY (CT) SCAN WAS TAKEN IN ORDER TO EVALUATE CAUSE OF HEADACHES AND THE RESULT SHOWED A LEAD FRACTURE. THE PATIENT WAS ALSO EXPERIENCING INADEQUATE PAIN RELIEF. UPON DEVICE INTERROGATION, IT WAS FOUND THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HEADACHES AND WAS ADMITTED TO THE HOSPITAL. A COMPUTED TOMOGRAPHY (CT) SCAN WAS TAKEN IN ORDER TO EVALUATE CAUSE OF HEADACHES AND THE RESULT SHOWED A LEAD FRACTURE. THE PATIENT WAS ALSO EXPERIENCING INADEQUATE PAIN RELIEF. UPON DEVICE INTERROGATION, IT WAS FOUND THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2522089 ARTISAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 16739514 08714729779919

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention