BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2844987 · Received November 26, 2012

    Report

    Report Number
    1644487-2012-03095
    Event Type
    Death
    Date Received
    November 26, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 2, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE EXPLANTED LEAD AND GENERATOR WERE RETURNED FOR PRODUCT ANALYSIS. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTIONS. THERE WERE MULTIPLE CUTS IN THE LEADS AND THE LEAD ASSEMBLY HAS REMNANTS OF WHAT APPEARS TO BE DRY BODY FLUIDS INSIDE THE INNER AND THE SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE IDENTIFIED TUBING OPENINGS AND THE ENDS OF THE RETURNED LEAD PORTIONS. IN THE PRODUCT ANALYSIS LAB, THE GENERATOR 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. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS; THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ON (B)(6) 2012 IT WAS REPORTED THAT THE VNS PATIENT HAS PASSED AWAY. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME. IT WAS LATER REPORTED THAT THE PATIENT¿S DEATH WAS BELIEVED TO BE ON (B)(6), 2012 AND BELIEVED TO BE SUDEP BUT THEY ARE STILL DETERMINING THE CAUSE OF DEATH. THE PATIENT HAD UNDERGONE VNS SYSTEM REPLACEMENT AROUND 10 DAYS PRIOR TO THE PATIENT'S DEATH AND THEREFORE THE PATIENT'S FAMILY WISHES FOR TESTING TO BE DONE ON THE EXPLANTED VNS PRODUCTS. WHEN ASKED WHETHER THE PATIENT EXHIBITED ANY RISK FACTORS THAT WOULD MAKE HIM MORE SUSCEPTIBLE TO SUDEP, THE PHYSICIAN STATED THAT THE PATIENT LIVED ALONE AND WAS MALE. THE NURSE LATER REPORTED THAT THE DATE OF DEATH WAS IN FACT (B)(6) 2012. THE PATIENT'S DEATH WAS NOT WITNESSED BUT THE PATIENT WAS FOUND BY HIS MOTHER. AN AUTOPSY WAS PERFORMED. THE PATIENT HAS 2ND GENERALIZED SEIZURES AND COMPLEX PARTIAL SEIZURES. IT WAS NOT KNOWN IF THE PATIENT HAS A HISTORY OF DRUG OR ALCOHOL ABUSE OR IF THE PATIENT HAS A HISTORY OF CARDIAC OR RESPIRATORY PROBLEMS. THE PATIENT HAS TAKEN CARBAMAZEPINE AND VALPROATE/VALPROIC ACID IN THE PAST. THE PATIENT WAS COMPLIANT WITH AEDS AND THE LAST KNOWN DRUG LEVELS WERE NOT AVAILABLE. THE CAUSE OF DEATH WAS STILL UNKNOWN AND THE RELATIONSHIP BETWEEN THE VNS SYSTEM AND THE CAUSE OF DEATH WAS ALSO NOT KNOWN. THE PATIENT'S VNS WAS TURNED OFF AT THE TIME OF DEATH. THE EXPLANTED LEAD AND GENERATOR WERE SENT TO THE MANUFACTURER FOR PRODUCT ANALYSIS ON (B)(6) 2012 BUT HAVE NOT BEEN RECEIVED TO DATE. A SUDEP EVALUATION WAS PERFORMED BY THE MANUFACTURER WHICH INDICATED THAT THE DEATH WAS PROBABLE SUDEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202121

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death