BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 4276201 · Received November 25, 2014

    Report

    Report Number
    1000165971-2014-00652
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 21, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S.; HOWEVER, IT IS SIMILAR TO REPLY DR OR SR MODELS APPROVED UNDER P950029.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED LEAD CONNECTION DIFFICULTIES DURING THE IMPLANT ATTEMPT OF THE SUBJECT PACEMAKER.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED LEAD CONNECTION DIFFICULTIES DURING THE IMPLANT ATTEMPT OF THE SUBJECT PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764658 REPLY NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY VDR S0030

    Patients

    Seq Age Sex Outcome Treatment
    1