BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 3772342 · Received April 25, 2014

    Report

    Report Number
    1000165971-2014-00224
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    October 1, 2013
    Report Date
    March 26, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, THE PHYSICIAN NOTICED THAT DURING THE FIRST INTERROGATION AT IMPLANTATION AFTER SAVING THE IMPEDANCE, THRESHOLD AND SENSING MEASUREMENTS, THESE MEASUREMENT VALUES DID NOT APPEAR IN THE PRINTOUTS. THEY APPEARED IN THE FOLLOWING INTERROGATIONS.

    Description of Event or Problem · 1

    REPORTEDLY, THE PHYSICIAN NOTICED THAT DURING THE FIRST INTERROGATION AT IMPLANTATION AFTER SAVING THE IMPEDANCE, THRESHOLD AND SENSING MEASUREMENTS, THESE MEASUREMENT VALUES DID NOT APPEAR IN THE PRINTOUTS. THEY APPEARED IN THE FOLLOWING INTERROGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252536 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY ESPRIT DR 2720

    Patients

    Seq Age Sex Outcome Treatment
    1