BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3122252 · Received May 17, 2013

    Report

    Report Number
    1000165971-2013-00243
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    SORIN GROUP ITALIA 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) 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, THE PT VISITED THE PHYSICIAN BECAUSE OF SHORT BREATHING AND TIREDNESS. THE PACEMAKER COULD NOT BE INTERROGATED AND PACING FAILURE WAS OBSERVED. IT WAS KNOWN THAT THE PT RECEIVED EXTERNAL DEFIBRILLATION SHOCK. THE DEVICE WAS RE-INTERROGATED IN ANOTHER CENTER, WHICH WAS SUCCESSFUL; HOWEVER, HIGH LEAD IMPEDANCE WAS OBSERVED IN BOTH CHANNELS. THE DEVICE WAS FORCED TO SWITCH TO STANDBY MODE, TO TRY TO REINITIALIZE COMPLETELY THE DEVICE AFTERWARDS; BUT THE PROCEDURE FAILED (LEAD IMPEDANCE STILL ABOVE 3 KOHM). THE PACEMAKER WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS. ANOTHER DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219506 REPLY NVZ SORIN GROUP ITALIA S.R.L. REPLY DR 2582

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention