BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROTHERM JK3

    MDR report key: 7604277 · Received June 14, 2018

    Report

    Report Number
    3002953813-2018-00034
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    May 15, 2018
    Report Date
    June 14, 2018
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE NO CASE STUDY FILES OR THE DEVICE WERE RETURNED FOR ANALYSIS. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE SERVICE REPORT, THE CAUSE FOR THE REPORTED EVENT WAS DUE TO A DAMAGED INTERNAL CIRCUIT BOARD. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES.

    Description of Event or Problem · 1

    DURING A RADIOFREQUENCY (RF) ABLATION PROCEDURE A CANCELLATION OCCURRED. DURING THE PROCEDURE THE RF GENERATOR THERMOMETER DID NOT FUNCTION. IT WAS NOT POSSIBLE TO CONTINUE AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443235 NEUROTHERM JK3 GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC JK3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other