BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3940096 · Received July 17, 2014

    Report

    Report Number
    1000165971-2014-00414
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 10, 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
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING A PACEMAKER REPLACEMENT PROCEDURE, FOLLOWING CONNECTION OF THE SUBJECT PACEMAKER TO THE EXISTING LEADS, PACING AND CAPTURE FAILURE WERE OBSERVED IN THE ECG TRACE. THE PHYSICIAN VISUAL VERIFIED PROPER LEAD CONNECTION, REPROGRAMMED THE DEVICE TO UNIPOLAR PACING MODE AND INSERTED THE DEVICE IN THE POCKET, BUT THE REPORTED ELECTRICAL ISSUES PERSISTED. ANOTHER PACEMAKER WAS SUBSEQUENTLY IMPLANTED INSTEAD.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING A PACEMAKER REPLACEMENT PROCEDURE, FOLLOWING CONNECTION OF THE SUBJECT PACEMAKER TO THE EXISTING LEADS, PACING AND CAPTURE FAILURE WERE OBSERVED IN THE ECG TRACE. THE PHYSICIAN VISUAL VERIFIED PROPER LEAD CONNECTION, REPROGRAMMED THE DEVICE TO UNIPOLAR PACING MODE AND INSERTED THE DEVICE IN THE POCKET, BUT THE REPORTED ELECTRICAL ISSUES PERSISTED. ANOTHER PACEMAKER WAS SUBSEQUENTLY IMPLANTED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418492 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2812

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R