BEUDAMED
    FDA Adverse Event Death Summary report: N

    REPLY

    MDR report key: 2202637 · Received August 8, 2011

    Report

    Report Number
    1000165971-2011-00285
    Event Type
    Death
    Date Received
    August 8, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 28, 2011
    Manufacturer
    SORIN CRM 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)(6) 2011. 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 PATIENT HAD HYPERPOTASSEMIA AND SOME SYMPTOMS OF HEART FAILURE. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011 DUE TO SUSPECTED GASTROINTESTINAL TRACT BLEEDING. ON (B)(6) 2011, PACING FAILURE WAS OBSERVED ON THE ECG MONITOR, THE SUBJECT DEVICE WAS INTERROGATED, EXTERNAL PACING WAS STARTED, BUT NON-CAPTURE WAS INDICATED. AFTER THE INTERROGATION, THE DEVICE WAS PROGRAMMED IN VVI MODE, WHICH WAS DIFFERENT FROM THE ORIGINAL SETTING. NON CAPTURE WAS ALSO OBSERVED AT THAT TIME (VVI, 80PPM, OUTPUT 5V/0.5MS). THE PACEMAKER WAS RE-PROGRAMMED TO THE PREVIOUS SETTING, DDD. A PULSE COULD THEN NO LONGER BE FOUND AND CARDIAC MASSAGE WAS STARTED. PACING FAILURE CONTINUED DURING THAT TIME. CARDIAC ARREST AND THEN PATIENT DEATH WERE CONFIRMED. THE PHYSICIAN INDICATED THAT THE PATIENT'S DEATH WAS NOT SUSPECTED DUE TO PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2497

    Patients

    Seq Age Sex Outcome Treatment
    1 Death