BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERA XT VR

    MDR report key: 5098988 · Received September 23, 2015

    Report

    Report Number
    3004209178-2015-18565
    Event Type
    Death
    Date Received
    September 23, 2015
    Date of Event
    August 25, 2015
    Report Date
    October 15, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED 11 DAYS FOLLOWING AN UPGRADE PROCEDURE. THE PATIENT WAS REPORTED TO BE BREATHLESS FOR SEVERAL DAYS PRIOR TO DEATH. THE PATIENT HAD A WITNESSED ARREST AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED. A SHOCK WAS WITNESSED FOLLOWED BY BEEPING HEARD FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). DEVICE INTERROGATION WAS PERFORMED AT THE FUNERAL HOME AND IT WAS NOTED THAT THERE WAS FAILURE TO DETECT A VENTRICULAR ARRHYTHMIA. SIX MINUTES AND 22 SECONDS ELAPSED PRIOR TO SHOCK DELIVERY RESULTING IN THE DEATH OF THE PATIENT. THE DEATH WAS CLASSIFIED AS A ARRHYTHMIC DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630139 EVERA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DVBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death