BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERA XT DR

    MDR report key: 3961647 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13602
    Event Type
    Death
    Date Received
    July 28, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A CONVERSATION WITH THE PHYSICIAN'S OFFICE THAT THE PATIENT IS DECEASED AND DIED WITHIN SIX WEEKS OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM IMPLANT. THE EXACT DATE OF DEATH IS UNKNOWN. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439418 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Death 6935M-62 LEAD, 4076-52 LEAD