BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC PHRENIC NERVE PAD

    MDR report key: 394944 · Received May 15, 2002

    Report

    Report Number
    394944
    Event Type
    Other
    Date Received
    May 15, 2002
    Date of Event
    April 22, 2002
    Report Date
    May 15, 2002
    Manufacturer
    MEDTRONIC USA, INC
    Product Code
    GZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT AORTIC VALVE REPLACEMENT AND SINGLE VESSEL CORONARY ARTERY BYPASS. POST OPERATIVELY PT RETURNED TO SURGERY FOR RE-EXPLORATION OF MEDIASTINAL BLEEDING. PT CODED NINE DAYS LATER AND EXPIRED. PT ALSO HAD TIA THE DAY BEFORE. DURING AUTOPSY ON 05/2002, A PHRENIC NERVE PAD WAS NOTED TO BE RETAINED IN THE PERICARDIAL SPACE ADJACENT TO THE HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PHRENIC NERVE PAD PHRENIC NERVE PAD GZE MEDTRONIC USA, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other