BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROPHYSIOLOGY (FIXED)

    MDR report key: 6262580 · Received January 18, 2017

    Report

    Report Number
    2182269-2017-00009
    Event Type
    Injury
    Date Received
    January 18, 2017
    Date of Event
    December 19, 2016
    Report Date
    December 19, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE 3005334138-2017-00004. FOLLOWING AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. FOLLOWING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED A PERICARDIAL EFFUSION ON THE RIGHT SIDE OF THE PATIENT'S HEART. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43863 ELECTROPHYSIOLOGY (FIXED) ELECTROPHYSIOLOGY (FIXED) MTE ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BARD CS CATHETER| BOSTON SCIENTIFIC BLAZER CATHETER| SJM TRANSSEPTAL INTRODUCER| SJM TRANSSEPTAL INTRODUCER