BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISAN

    MDR report key: 9359878 · Received November 21, 2019

    Report

    Report Number
    3006630150-2019-06716
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    July 30, 2019
    Report Date
    November 21, 2019
    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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8216-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 19843998, MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 50 CM. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATE TO THE EVENT OCCURRED DURING THE MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE PATIENTS IPG REVISION, IT WAS FOUND OUT THAT TWO OF THE FOUR TAILS FROM THE PATIENTS LEADS WERE FRACTURED. THE STIMULATION WAS STILL WHERE IT WAS NEEDED. NO FURTHER COURSE OF ACTION WILL BE TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152916 ARTISAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 19843998 08714729779902

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention