BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2182695 · Received July 8, 2011

    Report

    Report Number
    1000165971-2011-00249
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 30, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE PACEMAKER INVOLVED IN THIS REPORT WAS INTERROGATED ON (B)(6) 2011 (EMERGENCY FOLLOW-UP) BECAUSE THE PATIENT HAD BEEN FEELING DIZZINESS AND PALPITATIONS FOR ONE MONTH. VENTRICULAR PACING AT 70 MIN-1 WAS CONFIRMED ON SURFACE ECG (RECORDED BEFORE THE CHECK). UPON INTERROGATION, THE DEVICE WAS FOUND IN STANDBY MODE (BACKUP MODE) WHICH IS SAFETY MODE OF OPERATION. AFTER RE-INITIALIZATION, THE DEVICE WAS RE-PROGRAMMED TO THE PREVIOUS SETTINGS AND THE PACEMAKER CHECK WAS SUCCESSFULLY COMPLETED, AS REPORTED. ACCORDING TO THE PATIENT, NO SOURCE OF ELECTROMAGNETIC INTERFERENCE (EMI) COULD BE SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2481

    Patients

    Seq Age Sex Outcome Treatment
    1