BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY¿ ABLATION CATHETER

    MDR report key: 6802016 · Received August 17, 2017

    Report

    Report Number
    2030404-2017-00033
    Event Type
    Injury
    Date Received
    August 17, 2017
    Report Date
    August 17, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAD
    PMA / PMN Number
    P040042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF CARDIOLOGY CASES 16 (2017) 22-25. DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION, A PERICARDIAL EFFUSION OCCURRED. EIGHT MONTHS FOLLOWING THE PVI, EXERTIONAL DYSPNEA APPEARED. TRANSTHORACIC ECHOGRAPHY CONFIRMED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZED THE PATIENT. THE PATIENT WAS FOLLOWED AND DISCHARGED. THE CAUSE OF THE PERICARDIAL EFFUSION REMAINED UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580380 THERAPY¿ ABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention