BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRA CARDIAC ACCESS CATHETER

    MDR report key: 2192527 · Received August 5, 2011

    Report

    Report Number
    2017865-2011-05320
    Event Type
    Death
    Date Received
    August 5, 2011
    Date of Event
    June 8, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DQY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THIS REPORT IS LATE DUE TO AN ADMINISTRATIVE ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS SEARCHING THE CORONARY SINUS, A PERICARDIAL INJURY OCCURRED. THE PATIENT'S BLOOD PRESSURE WORSENED. THE PATIENT EXPIRED DUE TO MULTIPLE THROMBI. THE PHYSICIAN DOES NOT CONSIDER THE INCIDENT TO BE CAUSED BY THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA CARDIAC ACCESS CATHETER ACCESSORY DQY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 410213 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death