BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYMPHONY

    MDR report key: 2961759 · Received February 8, 2013

    Report

    Report Number
    9610579-2013-00007
    Event Type
    Death
    Date Received
    February 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 22, 2013
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE: (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, DURING THE FOLLOW-UP DATED (B)(6) 2012, THE PACEMAKER PACED IN VVIR MODE FOR 58% PACING SINCE (B)(6) 2011 (VENTRICULAR OUTPUT AT 2.5V - 0.35MS) AND BATTERY IMPEDANCE WAS AT 4.04 KOHM WITH AN ESTIMATED RESIDUAL LONGEVITY OF 41 MONTHS. (B)(6), BATTERY IMPEDANCE WAS AT 11.4 KOHM, I.E. THE ELECTIVE REPLACEMENT INDICATOR WAS REACHED; IN ADDITION, THE BATTERY CURVE SHOWED EXTREME CLIMB OVER 10 KOHM. IT WAS REPORTED ALSO THAT PATIENT WAS SEVERELY ILL AND DIED ON (B)(6) 2013 BUT DEATH WAS NOT PACEMAKER RELATED. AFTER PATIENT DEATH, THE PACEMAKER HAD BEEN EXPOSED TO LOW TEMPERATURES UNTIL EXPLANTATION ON (B)(6) 2013. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53663 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S040409

    Patients

    Seq Age Sex Outcome Treatment
    1 Death