BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 4699334 · Received April 16, 2015

    Report

    Report Number
    1644487-2015-04481
    Event Type
    Death
    Date Received
    April 16, 2015
    Date of Event
    January 20, 2015
    Report Date
    March 26, 2015
    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

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY ON (B)(6) 2015. THE CAUSE OF DEATH AND ITS RELATIONSHIP TO VNS ARE UNKNOWN. THE PATIENT¿S DEVICE WAS EXPLANTED AND WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. MONITORING OF THE DEVICE OUTPUT SIGNAL SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT. 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. THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. THERE IS NO EVIDENCE TO SUGGEST AN ANOMALY WITH THE RETURNED PORTIONS OF THE DEVICE. NOTE THAT SINCE THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION CANNOT BE MADE ON THAT PORTION OF THE LEAD. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. BASED ON THE LIMITED AVAILABLE INFORMATION ABOUT THE PATIENT¿S DEATH, AN INTERNAL CLASSIFICATION HAS DETERMINED THAT THE DEATH MAY BE POSSIBLE SUDEP.

    Description of Event or Problem · 1

    DEATH CERTIFICATE WAS RECEIVED ON (B)(6) 2015 AND INDICATED THE FOLLOWING ADDITIONAL INFORMATION. THE PATIENT¿S PLACE OF DEATH WAS IN THE HOSPITAL. DISPOSITION OF THE DECEASED WAS BURIAL. MANNER OF DEATH WAS NOT INDICATED. CAUSE OF DEATH WAS RESPIRATORY FAILURE (MINUTES) / STATUS EPILEPTICUS (DAYS)/ SEPSIS (DAYS)/ URINARY TRACT INFECTION (DAYS). OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO DEATH WERE INDICATED AS PROFOUND MENTAL RETARDATION, HISTORY OF STROKE, SEIZURES. AUTOPSY WAS NOT PERFORMED. PROGRAMMING HISTORY WAS REVIEWED FOR THE PATIENT¿S DEVICE. THE LAST KNOWN SETTINGS SYSTEM DIAGNOSTICS WERE FROM (B)(6) 2010 AND WERE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254243 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 2476

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death