BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROTHERM JK3

    MDR report key: 7168552 · Received January 5, 2018

    Report

    Report Number
    2184149-2018-00002
    Event Type
    Injury
    Date Received
    January 5, 2018
    Date of Event
    December 12, 2017
    Report Date
    February 2, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    GXD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CASE STUDY FILES OR PRODUCT WAS RETURNED FOR INVESTIGATION AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. 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 ABT SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION PROVIDED TO ABBOTT ON (B)(6) 2017, THE CAUSE FOR THE REPORTED EVENT IS CONSISTENT WITH A DEGRADED PRODUCT THAT IS AT THE END OF ITS EXPECTED LIFE CYCLE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE LESION POWER KNOB WAS DAMAGED CAUSING A PROCEDURE CANCELLATION. FOLLOWING ONE TREATMENT OF ABLATION FOR 180 SECONDS, THE OUTPUT COULD NOT BE INCREASED IF THE KNOB WAS TURNED. ANOTHER 180 SECOND ABLATION WAS SCHEDULED. THE KNOB WAS REMOVED AND THE CONTROL WAS DIRECTLY TURNED HOWEVER OUTPUT WOULD STILL NOT INCREASE. THE PROCEDURE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11573 NEUROTHERM JK3 GENERATOR, LESION, RADIOFREQUENCY GXD ST. JUDE MEDICAL, INC. JK3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other