BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3022728 · Received March 22, 2013

    Report

    Report Number
    1000165971-2013-00164
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THE PACEMAKER INVOLVED IN THIS MDR REPORT WAS IMPLANTED IN A PACING DEPENDENT PT TOGETHER WITH A NEW IMPLANTED LEAD. HOWEVER, FIVE MINS AFTER PLACING THE SUBJECT DEVICE IN THE POCKET, ABSENCE OF PACING WAS OBSERVED. THE DEVICE HAS BEEN INTERROGATED AND INTERNAL EGM SHOWED A KIND OF HIGH RATE NOISE SENSING (AT A FREQUENCY OF 8HZ) WITH HIGH AMPLITUDE WHICH INHIBITED PACING COMPLETELY. THE DEVICE HAS BEEN EXPLANTED IN EMERGENCY AND THE LEAD CONNECTED TO AN EXTERNAL PACING SYSTEM. LATER THE PT REC'D A NEW DEVICE. THE SUBJECT DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119087 REPLY NVZ SORIN CRM S.R.L. REPLY SR 2674

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention