BEUDAMED
    FDA Adverse Event Death Summary report: N

    REPLY

    MDR report key: 2644302 · Received June 29, 2012

    Report

    Report Number
    1000165971-2012-00253
    Event Type
    Death
    Date Received
    June 29, 2012
    Date of Event
    June 11, 2012
    Report Date
    June 20, 2012
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    PT DEATH FOLLOWING A HEART ATTACK WAS INDICATED BY THE PHYSICIAN. REPORTEDLY, THE SUBJECT DEVICE WAS IMPLANTED TO TREAT "SYNCOPE NODAL BLOCK". DURING THE PREVIOUS FOLLOW-UP, (B)(6) WEEKS AGO, THE LEVEL OF THE BATTERY WAS OK AND THERE WERE PROLONGED BURSTS OF TACHYCARDIA (JUNCTIONAL AND AF). FOLLOWING A HEART ATTACK ON (B)(6) 2012, AN SDA SHOCK WAS PERFORMED BY FIREMAN, AND THE PT WAS TRANSPORTED TO THE EMERGENCY ROOM. WHEN THE PT ARRIVED TO THE INTENSIVE CARE, THE SUBJECT DEVICE WAS MUTE UPON INTERROGATION ATTEMPTS, AND THERE WAS NO PACING UPON MAGNET APPLICATION. THE PT DIED AND THE PACING SYSTEM WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2545

    Patients

    Seq Age Sex Outcome Treatment
    1 Death