BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER, ELECTROPHYSIOLOGY

    MDR report key: 5819055 · Received July 25, 2016

    Report

    Report Number
    3005334138-2016-00042
    Event Type
    Injury
    Date Received
    July 25, 2016
    Date of Event
    June 21, 2016
    Report Date
    June 27, 2016
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 INCIDENT 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

    RELATED MFR REPORT NUMBERS 2030404-2016-00031, 2030404-2016-00032, 3005334138-2016-00041, 2030404-2016-00033. FOLLOWING AN AF ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED. THE PATIENT BECAME HYPOTENSIVE AND EXPERIENCED RETROSTERNAL BACK PAIN AND AN ECHOCARDIOGRAM REVEALED A TAMPONADE. THE PATIENT RETURNED TO THE CATH LAB AND A PERICARDIOCENTESIS WAS PERFORMED, WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472354 INTRODUCER, ELECTROPHYSIOLOGY INTRODUCER DYB ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention COOLPATH DUO MG ENABLED CATHETER