BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2992298 · Received March 1, 2013

    Report

    Report Number
    1000165971-2013-00101
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 15, 2013
    Manufacturer
    SORIN CRM S.R.I.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PACEMAKER CHECK WAS PERFORMED BECAUSE THE PATIENT WAS SHOWING OVERSENSING SYMPTOMS (HE COMPLAINED FROM BRADYCARDIA (AROUND 50BPM) AND WAS FEELING TIRED). DURING THE CHECK, SPONTANEOUS RHYTHM (50BPM) AND HIGH VENTRICULAR LEAD IMPEDANCE (>3000OHMS) WERE CONFIRMED. INTERMITTENT PACING FAILURE (1-2 SPIKES) WAS OBSERVED IN CERTAIN PROVOCATIVE CONDITIONS (WHEN THE PATIENT MOVED AN ARM UP AND DOWN, WHEN SOME PRESSURE WAS APPLIED AROUND POCKET AREA). ON (B)(6) 2013, A RE-INTERVENTION WAS PERFORMED. LEAD CONNECTOR PIN SEEMED TO BE FULLY INSERTED INTO THE PACEMAKER PORT UNDER FLUOROSCOPIC IMAGING. DURING THE RE-INTERVENTION, UNDERSENSING OF SPONTANEOUS BEAT WAS CONFIRMED. WHEN THE PHYSICIAN EXTRACTED THE PACEMAKER AND PULLED THE VENTRICULAR LEAD, THE LEAD CAME OUT FROM THE PORT WITHOUT UNSCREWING. THE LEAD WAS TESTED BY AN ANALYZER AND NORMAL VALUES WERE OBTAINED. SAME LEADS WERE RE-CONNECTED TO THE SAME PACEMAKER, AND NORMAL VALUES WERE MEASURED AT THE POST-IMPLANT CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89306 REPLY NVZ SORIN CRM S.R.I. REPLY DR 2637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention