BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 6124408 · Received November 23, 2016

    Report

    Report Number
    1644487-2016-02723
    Event Type
    Death
    Date Received
    November 23, 2016
    Date of Event
    January 23, 2016
    Report Date
    January 12, 2017
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ANALYSIS WAS PERFORMED ON THE EXPLANTED GENERATOR. DURING ANALYSIS, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. ANALYSIS WAS PERFORMED ON THE RETURNED LEAD. SINCE A SIGNIFICANT PORTION OF THE LEAD INCLUDING (THE ELECTRODE ARRAY) WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A MORTUARY REPRESENTATIVE THAT THE PATIENT PASSED AWAY. THE DEVICE WAS EXPLANTED (B)(6) 2016 PER AN ONLINE OBITUARY, THE PATIENT PASSED (B)(6) 2016. PER AN AUTOMATIC BATTERY LIFE CALCULATION, THE DEVICE WAS LIKELY FUNCTIONING AT THE TIME OF THE PATIENT'S DEATH. THE MORTUARY WAS CONTACTED AND THEY WOULD NOT RELEASE A DEATH CERTIFICATE OR INFORMATION WITHOUT FAMILY CONSENT. ALL THEY COULD DO WAS CONFIRM THE PATIENT'S PASSING. THE GENERATOR HAS NOT BEEN RECEIVED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR AND LEAD WERE RECEIVED ON 11/22/2016. ANALYSIS IS UNDERWAY, BUT HASN'T BEEN COMPLETED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776369 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 202965

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death