BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3853274 · Received June 6, 2014

    Report

    Report Number
    1000165971-2014-00324
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 2, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS OF THE RETURNED DEVICE SHOWED PROPER ELECTRICAL AND MECHANICAL FUNCTION.

    Description of Event or Problem · 1

    DURING THE IMPLANT ATTEMPT OF THE SUBJECT PACEMAKER THE PHYSICIAN REPORTED DIFFICULTY IN INSERTING THE VENTRICULAR LEAD INTO THE PORT. ONCE INSERTED THERE WAS NO PACING LEADING TO A PERIOD OF ASYSTOLE. A DIFFERENT DEVICE WAS CONNECTED TO THE SAME LEAD WITH NO ISSUES AND APPROPRIATE PACING.

    Description of Event or Problem · 1

    DURING THE IMPLANT ATTEMPT OF THE SUBJECT PACEMAKER THE PHYSICIAN REPORTED DIFFICULTY IN INSERTING THE VENTRICULAR LEAD INTO THE PORT. ONCE INSERTED THERE WAS NO PACING LEADING TO A PERIOD OF ASYSTOLE. A DIFFERENT DEVICE WAS CONNECTED TO THE SAME LEAD WITH NO ISSUES AND APPROPRIATE PACING.

    Description of Event or Problem · 1

    DURING THE IMPLANT ATTEMPT OF THE SUBJECT PACEMAKER, THE PHYSICIAN REPORTED DIFFICULTY IN INSERTING THE VENTRICULAR LEAD INTO THE PORT. ONCE INSERTED THERE WAS NO PACING LEADING TO A PERIOD OF ASYSTOLE. A DIFFERENT DEVICE WAS CONNECTED TO THE SAME LEAD WITH NO ISSUES AND APPROPRIATE PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332681 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY ESPRIT DR 2788

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention