BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 3970702 · Received July 31, 2014

    Report

    Report Number
    1000165971-2014-00434
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 1, 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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTRICULAR TACHYCARDIA (VT) OF (B)(6) 2014 AT 7:50PM WAS NOT RECORDED IN DEVICE MEMORY. AN ANALYSIS IS REQUESTED.

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTRICULAR TACHYCARDIA (VT) OF (B)(6) 2014 WAS NOT RECORDED IN DEVICE MEMORY. AN ANALYSIS IS REQUESTED.

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTRICULAR TACHYCARDIA (VT) OF (B)(6) 2014 AT 7:50PM WAS NOT RECORDED IN DEVICE MEMORY. AN ANALYSIS IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446806 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2503

    Patients

    Seq Age Sex Outcome Treatment
    1