BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 4091215 · Received September 16, 2014

    Report

    Report Number
    1000165971-2014-00527
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 18, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE IMPLANTATION OF A NEW REPLY DR (SN (B)(4)) STIMULATION DID NOT START IMMEDIATELY AFTER CONNECTION THE PACEMAKER TO A LEAD. AFTER SCREWING THE VENTRICULAR LEAD (1ST SOUND) AND AFTER SCREWING THE ATRIAL LEAD (2ND SOUND) STIMULATION STARTS WITH A DELAY. PACEMAKER RATE WAS PROGRAMMED TO 70MIN-1 BEFORE IMPLANTATION. THE PATIENT¿S SPONTANEOUS HEART RATE WAS ABOUT 50 MIN-1. NOTE THAT THE PATIENT IN THIS CASE IS NOT PACEMAKER-DEPENDENT.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE IMPLANTATION OF A NEW REPLY DR (SN (B)(4)) STIMULATION DID NOT START IMMEDIATELY AFTER CONNECTION THE PACEMAKER TO A BIPOLAR LEAD, NEITHER UNIPOLAR NOR BIPOLAR. AFTER SCREWING THE VENTRICULAR LEAD (1ST SOUND) AND AFTER SCREWING THE ATRIAL LEAD (2ND SOUND) STIMULATION STARTS WITH A DELAY. PACEMAKER RATE WAS PROGRAMMED TO 70MIN-1 BEFORE IMPLANTATION. THE PATIENT¿S SPONTANEOUS HEART RATE WAS ABOUT 50 MIN-1. NOTE THAT THE PATIENT IN THIS CASE IS NOT PACEMAKER-DEPENDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573302 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2698

    Patients

    Seq Age Sex Outcome Treatment
    1