BEUDAMED
    FDA Adverse Event Death Summary report: N

    TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED

    MDR report key: 10160190 · Received June 16, 2020

    Report

    Report Number
    9680001-2020-00036
    Event Type
    Death
    Date Received
    June 16, 2020
    Date of Event
    May 19, 2020
    Report Date
    July 30, 2020
    Manufacturer
    ST. JUDE MEDICAL (AFD-PLYMOUTH)
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED DEATH COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT. FURTHER INFORMATION REGARDING THE EVENT WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE: 3005334138-2020-00236. FOLLOWING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE PATIENT EXPIRED. THE ABLATION PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. PRIOR TO DISCHARGE THE FOLLOWING DAY, THE PATIENT DIED. THE CAUSE OF DEATH IS UNKNOWN AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622730 TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL (AFD-PLYMOUTH)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ADVISOR HD GRID MAPPING CATHETER