BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2792263 · Received October 12, 2012

    Report

    Report Number
    1000165971-2012-00384
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 28, 2012
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2012. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    PACING FAILURE WAS REPORTED RELATIVE TO THE SUBJECT PACEMAKER ON A PT SUFFERING BRADYCARDIA. IT WAS OBSERVED THAT THE DEVICE DID NOT PACE EVEN WHEN IT WAS SET INTO A RATE OF 60 BPM, SUBSEQUENTLY THE PHYSICIAN REPLACED THE DEVICE. THE PACEMAKER WAS INTERROGATED AFTER EXPLANT AND PERIODIC SENSING SIGNAL WAS NOTED EVEN WITH THE LEADS DISCONNECTED. WHEN SENSING TEST WAS PERFORMED, V-SPIKES WERE OBSERVED IN THE A-EGM WHILE A-SPIKES WERE IDENTIFIED IN THE V-EGM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2635

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention