BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERA XT VR

    MDR report key: 4920156 · Received July 16, 2015

    Report

    Report Number
    3004209178-2015-13579
    Event Type
    Death
    Date Received
    July 16, 2015
    Date of Event
    April 5, 2015
    Report Date
    June 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S SPOUSE THAT THE DEVICE CONTRIBUTED TO THE PATIENT¿S DEATH. THE PATIENT WAS AT A RELATIVE¿S HOME AND THE DEVICE STARTED BEEPING. THE RELATIVE DID CARDIOPULMONARY RESUSCITATION (CPR) AND PATIENT WAS TRANSPORTED TO THE HOSPITAL AND PATIENT PASSED AWAY DURING THE STAY. THE SPOUSE REPORTED ¿THE PATIENT WAS SHOCKED TWICE AND PER ELECTROPHYSIOLOGIST (EP), DID NOT HAVE RESERVE TO CONTINUE¿. THE SPOUSE WOULD LIKE TO KNOW IF THE DEVICE SHOCKED OR NOT AND WHAT HAPPENED SPECIFICALLY. SPOUSE ALSO UNDERSTOOD THERE WERE 12 INSTANCES PATIENT WAS IN VENTRICULAR HEART RATES OVER 200 BPM. SPOUSE FURTHER REPORTED DEATH CERTIFICATE NOTED PRIMARY DIAGNOSIS: CORONARY ARTERY DISEASE AND THEN MALIGNANT VENTRICULAR ARRHYTHMIA AND ISCHEMIC CARDIOMYOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462496 EVERA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DVBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death 6947M62 LEAD