BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENPULSE

    MDR report key: 1982840 · Received February 9, 2011

    Report

    Report Number
    6000094-2011-00023
    Event Type
    Death
    Date Received
    February 9, 2011
    Date of Event
    August 9, 2008
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S032
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED DUE TO A CARDIAC ARREST INITIATED FROM VENTRICULAR TACHYCARDIA AND RESULTED IN BRAIN DEATH. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPULSE IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. E2DR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death