BEUDAMED
    FDA Adverse Event Death Summary report: N

    REPLY

    MDR report key: 2992131 · Received March 1, 2013

    Report

    Report Number
    1000165971-2013-00110
    Event Type
    Death
    Date Received
    March 1, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 19, 2013
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, DUE TO CARDIOPULMONARY ARREST, THE PT WAS TAKEN TO THE HOSPITAL, WHERE SEVERAL EXTERNAL DEFIBRILLATOR SHOCKS WERE APPLIED TO RESUSCITATE THE PT. AFTER TREATMENT SPONTANEOUS RHYTHM RETURNED TO AROUND 90BPM. SUBSEQUENT INTERROGATION ATTEMPTS OF THE SUBJECT PACEMAKER WERE UNSUCCESSFUL, THEREFORE, A TEMPORARY PACEMAKER WAS SET. IN THE EVENING OF THE SAME DAY, THE PT'S CONDITION WORSENED RESULTING IN DEATH. THE PHYSICIAN COMMENTED THAT THE PACEMAKER FUNCTION WAS NOT RELATED TO THE CAUSE OF THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89410 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2624

    Patients

    Seq Age Sex Outcome Treatment
    1 Death