BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2033851 · Received February 11, 2011

    Report

    Report Number
    1000165971-2011-00079
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 31, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FEBRUARY 11, 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 PHYSICIAN REPORTED THAT UPON SCHEDULED FOLLOW-UP OF THIS PACEMAKER ON (B)(6) 2011, EMBEDDED HOLTER MEMORIES (AIDA) COULD NOT BE READ (DATA REMAINED EMPTY ON THE PROGRAMMER SCREEN), EVEN THOUGH THE PROGRAMMING HEAD WAS LEFT FOR A LONG TIME ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2487

    Patients

    Seq Age Sex Outcome Treatment
    1