BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN

    MDR report key: 19581642 · Received June 21, 2024

    Report

    Report Number
    3006630150-2024-03933
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    April 24, 2024
    Report Date
    June 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729779902
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC UPN: M365SC14160 MODEL: SC-1416 SERIAL: (B)(6) BATCH: 221338.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE (MFR. REPORT NO.: 3006630150-2024-03225), THE PHYSICIAN DISCOVERED THAT THE LEAD WAS COILED UP ON TOP OF THE PREVIOUS IPG AND UNINTENTIONALLY CUT THE LEAD OF THE PADDLE. CONSEQUENTLY, THE PATIENT REQUIRED A PADDLE LEAD REPLACEMENT. DURING THE PROCEDURE, IT WAS FOUND THAT THE IPG HAD HIGH IMPEDANCES. THUS, THE PHYSICIAN DECIDED TO REPLACE THE IPG AS WELL. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218295 ARTISAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 19303046 08714729779902

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention