BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERA-I DR

    MDR report key: 1050056 · Received May 20, 2008

    Report

    Report Number
    2647346-2008-00268
    Event Type
    Death
    Date Received
    May 20, 2008
    Date of Event
    August 10, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: FURTHER ANALYSIS WAS PERFORMED ON THE ATRIAL LEAD WHICH INDICATED DISTAL CONDUCTOR FRACTURED; FULL LEAD IN SEGMENTS WAS RETURNED FOR ANALYSIS. EVALUATION SUMMARY: NO ANOMALIES WERE FOUND. PRELIMINARY AUTOPSY RESULTS WERE RECEIVED WHICH IDENTLIFIES THE CAUSE OF DEATH AS HYPOXIC ISCHEMIC ENCEPHALOPATHY DUE TO CARDIAC ARRHYTHMIA DUE TO CARDIAC PACEMAKER FAILURE. THE REPORT STATES THAT BOTH LEADS WERE APPROPRIATELY POSITIONED.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERA-I DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 7960IB ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O 5024M IMPLANTABLE PACING LEAD