BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN

    MDR report key: 11850844 · Received May 19, 2021

    Report

    Report Number
    3006630150-2021-02232
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    April 29, 2021
    Report Date
    May 19, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8116700, MODEL: SC-8116-70, SERIAL: (B)(4), BATCH: 127318.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PHYSICIAN WAS TRYING TO PLUG TWO TAILS DURING PATIENTS IPG REVISION, ONE OF THE TAILS HAD ALL CONTACTS OUT. THE PHYSICIAN OPTED TO CONNECT TO AN ADAPTER AND WAS ABLE TO REGAIN 4 OUT OF 8 CONTACTS. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746009 ARTISAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8116-50 117114

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention