BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULDE GEN MODEL 103

    MDR report key: 3061952 · Received April 16, 2013

    Report

    Report Number
    1644487-2013-01035
    Event Type
    Death
    Date Received
    April 16, 2013
    Date of Event
    March 26, 2012
    Report Date
    March 19, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEATH DATE IS (B)(6 )2012 PER THE DEATH CERTIFICATE.

    Additional Manufacturer Narrative · 1

    THE CORRECT EXPLANT DATE PER THE DEATH CERTIFICATE WAS (B)(6) 2012; THIS INFORMATION WAS INADVERTENTLY OMITTED FROM FOLLOW-UP MDR REPORT #2.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT IMPLANTED WITH VNS HAD DIED, BUT NO OTHER INFORMATION WAS KNOWN. THE DATE OF DEATH AND VNS GENERATOR EXPLANT DATE ARE APPROXIMATE. THE VNS WAS EXPLANTED AND RETURNED FOR ANALYSIS ON (B)(6) 2013. NO ANOMALIES WERE NOTED WITH THE GENERATOR, AND THE GENERATOR PERFORMED PER SPECIFICATIONS. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    ADDITIONAL VNS PROGRAMMING HISTORY WAS OBTAINED WHICH DOCUMENTED NO HIGH IMPEDANCE THROUGH (B)(6) 2012. AN IMPEDANCE CHANGE OCCURRED ON (B)(6) 2011 FROM 4087 OHMS TO 3000 OHMS, INDICATING NORMAL DEVICE FUNCTION.

    Description of Event or Problem · 1

    THE DEATH CERTIFICATE WAS RECEIVED TO THE MANUFACTURER WHICH NOTED THE DEATH DATE WAS (B)(6) 2012. THE DEATH OCCURRED IN THE PATIENT¿S HOME. THE CAUSE OF DEATH IS LISTED AS COMPLICATIONS OF CEREBRAL PALSY (15 MINUTES) AND CEREBRAL PALSY (YEARS). THE PATENT HAD COMORBID CONDITIONS OF MENTAL RETARDATION, SEIZURE DISORDER, AND RIGHT HEMIPARESIS. NO AUTOPSY WAS PERFORMED. THE PATIENT WAS CREMATED ON (B)(6) 2012. THE PATIENT WAS LAST SEEN ALIVE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162954 PULDE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 200812

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death