BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT DR

    MDR report key: 2052264 · Received April 12, 2011

    Report

    Report Number
    2647346-2011-00538
    Event Type
    Death
    Date Received
    April 12, 2011
    Date of Event
    February 25, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM CANADA INDICATED THE PATIENT HAD AN ADDITIONAL LEAD AT THE TIME OF DEATH. THE LEAD 5076 IS BEING SUBMITTED VIA A INDIVIDUAL MDR. 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 WITH AN IMPLANTABLE CARDIAC DEFIBRILLATOR DIED OF SUDDEN CARDIAC DEATH AND ISCHEMIC HEART DISEASE. THE PATIENT HAD A HISTORY OF ATRIAL FLUTTER AND AN ABLATION PROCEDURE TWENTY THREE DAYS PRIOR TO DEATH. NO RECORDS HAVE BEEN MADE AVAILABLE OTHER THAN A DEATH CERTIFICATE. IT WAS NOTED BY THE CORONER THAT IT WAS A "NATURAL EXPECTED DEATH" AND NO CORONERS REPORT WAS WRITTEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA XT DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D354DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death