BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3931147 · Received July 14, 2014

    Report

    Report Number
    1000165971-2014-00406
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 7, 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
    FR
    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

    ELECTRICAL ISSUES WERE REPORTED TO THE SUBJECT PACEMAKER. REPORTEDLY WHEN THE PATIENT WAS HOSPITALIZED IN THE BEGINNING OF (B)(6) 2014 DUE TO CARDIAC ARREST, HIGH VENTRICULAR IMPEDANCES WERE IDENTIFIED. ON (B)(6) 2014, THE PACEMAKER WAS REPLACED. A NEW V LEAD WAS IMPLANTED AND THE OLD ONE WAS ABANDONED. THE PHYSICIAN SUSPECTS A DEFECT RELATED TO THE CONNECTOR PORT.

    Description of Event or Problem · 1

    ELECTRICAL ISSUES WERE REPORTED TO THE SUBJECT PACEMAKER. REPORTEDLY WHEN THE PATIENT WAS HOSPITALIZED IN THE BEGINNING OF (B)(6) 2014 DUE TO CARDIAC ARREST, HIGH VENTRICULAR IMPEDANCES WERE IDENTIFIED. ON (B)(6) 2014 THE PACEMAKER WAS REPLACED. A NEW V LEAD WAS IMPLANTED AND THE OLD ONE WAS ABANDONED. THE PHYSICIAN SUSPECTS A DEFECT RELATED TO THE CONNECTOR PORT.

    Description of Event or Problem · 1

    ELECTRICAL ISSUES WERE REPORTED TO THE SUBJECT PACEMAKER. REPORTEDLY, WHEN THE PATIENT WAS HOSPITALIZED IN THE BEGINNING OF (B)(6) 2014 DUE TO CARDIAC ARREST, HIGH VENTRICULAR IMPEDANCES WERE IDENTIFIED. ON (B)(6) 2014, THE PACEMAKER WAS REPLACED. A NEW V LEAD WAS IMPLANTED AND THE OLD ONE WAS ABANDONED. THE PHYSICIAN SUSPECTS A DEFECT RELATED TO THE CONNECTOR PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410657 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2563

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention