BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY ABLATION CATHETER

    MDR report key: 11730965 · Received April 27, 2021

    Report

    Report Number
    2030404-2021-00028
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    April 20, 2021
    Report Date
    April 27, 2021
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING A ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) PROCEDURE, A COMPLETE ATRIOVENTRICULAR BLOCK OCCURRED. THE PROCEDURE WAS PERFORMED AS NORMAL, HOWEVER, DISPLACEMENT OF THE CATHETERS OCCURRED. WHILE APPLYING RADIOFREQUENCY AT THE INTRINSIC CONDUCTION REGION (PARAHISSIAN REGION), A COMPLETE ATRIOVENTRICULAR BLOCK OCCURRED. THE PATIENT WAS AT REST FOR 30 MINUTES IN ORDER TO OBSERVE A RETURN OF NORMAL SINUS RHYTHM. AFTER 30 MINUTES, THE COMPLETE HEART BLOCK REMAINED REQUIRING A TEMPORARY PACEMAKER TO BE IMPLANTED AND THE PATIENT WAS MOVED TO THE ICU. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630116 THERAPY ABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL IBI-83459 7441968

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention