BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2802665 · Received October 19, 2012

    Report

    Report Number
    1000165971-2012-00398
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 10, 2012
    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

    ON (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

    DURING A REGULAR FOLLOW-UP PERFORMED ON (B)(6) 2012, ATRIAL LEAD IMPEDANCE ABOVE 3 KOHMS WAS CONFIRMED. ABSENCE OF PACING AND SENSING WERE ALSO CONFIRMED ON THE ATRIAL SIDE. NEVERTHELESS, X-RAY PICTURE DID NOT REVEAL ATRIAL LEAD FAILURE, AND REPORTED BEHAVIOR WAS NOT ASSOCIATED WITH ANY PT SYMPTOMS. PHYSICIAN DECIDED NOT TO RE-INTERVENE; PACEMAKER WAS REPROGRAMMED IN VVI MODE; AND A NEW PACEMAKER CHECK HAS BEEN SCHEDULED WITHIN APPROXIMATELY ONE MONTH TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2570

    Patients

    Seq Age Sex Outcome Treatment
    1