BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERA XT DR

    MDR report key: 5114396 · Received September 30, 2015

    Report

    Report Number
    3004209178-2015-19039
    Event Type
    Death
    Date Received
    September 30, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 4, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 THE PATIENT IS DECEASED AND DIED POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. IT WAS FURTHER REPORTED THAT THE WHEN THE PATIENT WAS MOVED FROM THE CATH LAB TO THE PATIENT ROOM THE PATIENT BECAME UNRESPONSIVE. THE PATIENT WAS PLACED ON A MONITOR AND A PACED RHYTHM WAS OBSERVED BUT NO PULSE. RESUSCITATION EFFORTS WERE INITIATED. AN ECHOCARDIOGRAM WAS TAKEN AND DEMONSTRATED PULSELESS ELECTRICAL ACTIVITY AND NO PERICARDIAL EFFUSION. DURING THE RESUSCITATION EFFORTS THE PATIENT DEVELOPED MULTIPLE EPISODES OF VENTRICULAR FIBRILLATION (VF) WHICH WERE SUCCESSFULLY DEFIBRILLATED THROUGH THE DEVICE. RESUSCITATION EFFORTS WERE NOT SUCCESSFUL AND THE PATIENT DIED. IT WAS FURTHER NOTED THAT XRAY INDICATED THE LEADS WERE IN GOOD PLACEMENT AND THERE WERE NO ISSUES DURING IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646066 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Death