BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2850553 · Received November 16, 2012

    Report

    Report Number
    1000165971-2012-00434
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 30, 2012
    Manufacturer
    SORIN C.R.M., S.R.L.
    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

    ELECTRICAL ANOMALIES WERE REPORTED TO THE SUBJECT PACEMAKER IMPLANTED WITH A Y-ADAPTER. REPORTEDLY, THE SUBJECT PACEMAKER REPLACED A DEVICE WHICH HAD TWO LEFT VENTRICULAR LEADS CONNECTED BY THE Y-ADAPTER. THE FORMER PACING SYSTEM AND THE ADAPTER WERE NON-SORIN. DURING THE REPLACEMENT PROCEDURE NO ELECTRICAL ANOMALIES WERE NOTED TO THE Y-ADAPTER WHEN IT WAS DISCONNECTED AND MEASURED BY AN ANALYZER. THE ADAPTER WAS THEN CONNECTED TO THE SUBJECT PACEMAKER. WHEN THE DEVICE WAS OUT OF THE BODY, INTERMITTENT PACING WAS OBSERVED; WHEN IT WAS PLACED INSIDE THE POCKET, PACING FAILURE COULD NOT BE CONFIRMED. AFTER THE INTERVENTION, PACING FAILURE WAS OBSERVED AGAIN ON THE ECG. ONE DAY AFTER, A PACEMAKER REVISION WAS PERFORMED. NO ANOMALIES WERE NOTED ON THE ADAPTER PORTION WHEN THE DEVICE WAS EXTRACTED FROM THE POCKET. THE Y-ADAPTER WAS DISCONNECTED AND NORMAL ELECTRICAL MEASUREMENTS WERE OBTAINED; THE LEADS WERE DISCONNECTED AND MEASURED BY AN ANALYZER AND NO ANOMALIES WERE NOTED. THE Y-ADAPTER WAS REPLACED BUT INTERMITTENT PACING FAILURE WAS STILL OBSERVED. WHEN THE DEVICE WAS CHECKED BY THE PROGRAMMER, PACING PULSES WERE DELIVERED BY THE DEVICE AND NO OVERSENSING WAS OBSERVED. BUT PACING FAILURE WAS OBSERVED WHEN THE PHYSICIAN TOUCHED THE CONNECTOR PORTION. A NEW NON-SORIN DEVICE WAS IMPLANTED WITH ONE LEAD CONNECTED BY A NEW NON-SORIN ADAPTER; THE OTHER LEAD WAS CAPPED AND LEFT INSIDE THE BODY. NORMAL PACING WAS CONFIRMED EVEN WHEN THE POCKET AREA WAS TOUCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN C.R.M., S.R.L. REPLY SR 2616

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention