BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRODUCT OR MODEL UNK

    MDR report key: 1581760 · Received January 14, 2010

    Report

    Report Number
    2135394-2010-00002
    Event Type
    Death
    Date Received
    January 14, 2010
    Report Date
    December 18, 2009
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWS
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL AND SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED, AND NO PRODUCT IS EXPECTED TO BE RETURNED. DEVICE HISTORY REVIEW AND ANALYSIS CAN NOT BE PERFORMED. RESULTS: DEVICE HISTORY REVIEW AND ANALYSIS CANNOT BE PERFORMED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. NO PRODUCT WAS RETURNED FOR ANALYSIS. CONCLUSION: THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON RECEIPT, THIS EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT FILED.

    Description of Event or Problem · 1

    MEDTRONIC CARDIOVASCULAR RECEIVED INFORMATION THROUGH A LEGAL REPRESENTATION, ALLEGING AN OCTOPUS DEVICE MALFUNCTIONED AND DESTABILIZED, CAUSING EROSION INTO THE PATIENT'S RIGHT VENTRICLE. THIS WAS ALLEGED TO CAUSE SERIOUS COMPLICATIONS RESULTING IN THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODUCT OR MODEL UNK UNK DWS MEDTRONIC PERFUSION SYSTEMS UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death