BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTISYS¿ MAIN ADAPTER ASSEMBLY

    MDR report key: 12983505 · Received December 13, 2021

    Report

    Report Number
    2184149-2021-00397
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 16, 2021
    Report Date
    January 5, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED. THE DHR REVIEW WAS NOT REQUIRED AS SERIAL NUMBER AND BATCH NUMBER IDENTIFICATION WAS NOT AVAILABLE. NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED. THE ISSUE WILL CONTINUE TO BE MONITORED FOR TRENDS AND REVIEWED IN QDR (QUALITY DATA REVIEW).

    Description of Event or Problem · 0

    BEFORE THE PROCEDURE, THE POWER CABLE WAS NOTED TO BE BURNT AND SCORCHED. THE POWER CABLE WAS EXCHANGED AND THE PROCEDURE WAS ABLE TO BE COMPETED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887046 TACTISYS¿ MAIN ADAPTER ASSEMBLY CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL 100103073 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown