BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 3852890 · Received June 6, 2014

    Report

    Report Number
    1000165971-2014-00318
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    October 23, 2013
    Report Date
    May 7, 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
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING FOLLOW UP ON (B)(6) 2013, THE DEVICE WAS FOUND IN STAND-BY MODE (PREVIOUS FOLLOW UP ON (B)(6) 2013). THE RE-INITIALISATION WAS PERFORMED NORMALLY. THE PATIENT UNDERWENT RADIOTHERAPY, BUT DATES ARE UNKNOWN.

    Description of Event or Problem · 1

    DURING FOLLOW UP ON (B)(6) 2013, THE DEVICE WAS FOUND IN STAND-BY MODE (PREVIOUS FOLLOW UP ON (B)(6) 2013). THE RE-INITIALISATION WAS PERFORMED NORMALLY. THE PATIENT UNDERWENT RADIOTHERAPY, BUT DATES ARE UNKNOWN.

    Description of Event or Problem · 1

    DURING FOLLOW UP ON (B)(6) 2013, THE DEVICE WAS FOUND IN STAND-BY MODE (PREVIOUS FOLLOW UP ON (B)(6) 2013). THE RE-INITIALISATION WAS PERFORMED NORMALLY. THE PATIENT UNDERWENT RADIOTHERAPY, BUT DATES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331556 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2486

    Patients

    Seq Age Sex Outcome Treatment
    1