BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE VELOCITY¿ SYSTEM AMPLIFIER

    MDR report key: 16416554 · Received February 22, 2023

    Report

    Report Number
    2184149-2023-00048
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    February 20, 2023
    Report Date
    May 2, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    PMA / PMN Number
    K160187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED ERROR MESSAGE AND SUBSEQUENT DELAY REMAIN UNKNOWN.

    Description of Event or Problem · 0

    DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, AN ERROR MESSAGE WAS NOTED AND TROUBLESHOOTING WAS DONE CAUSING A DELAY. WHILE ABLATING UP TO 35W, THE COMPUTER DISPLAYED AN ERROR MESSAGE "ERREUR AMPLIFICATEUR. DECONNECTEZ-VOUS ET ÉTEIGNEZ PUIS RALLUMEZ LE PTA ENSITE VELOCITY ET L'AMPLIFICATEUR AVANT DE REDÉMARRER." TRANSLATED FROM FRENCH: "AMPLIFIER ERROR. DISCONNECT AND TURN THE ENSITE VELOCITY PTA AND AMPLIFIER OFF AND ON BEFORE RESTARTING." THE AMPLIFIER WAS SHUT DOWN AND REBOOTED. THE ABLATION CATHETER, GENERATOR, PUMP AND TACTISYS WERE ALL EXCHANGED, WHICH DID NOT RESOLVE THE ISSUE. ABLATION FUNCTIONED UP TO 30W AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676841 ENSITE VELOCITY¿ SYSTEM AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. 100015555

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown