BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3930286 · Received July 11, 2014

    Report

    Report Number
    1644487-2014-01764
    Event Type
    Death
    Date Received
    July 11, 2014
    Date of Event
    October 17, 2012
    Report Date
    June 17, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. THE RELATIONSHIP OF THE DEATH TO VNS THERAPY IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT ON (B)(6) 2012, THE PATIENT¿S MOTHER HAD FOUND HIM IN THE BEDROOM BANGING HIS SIDE ON THE FLOOR, HAVING A GENERALIZED SEIZURE. A DOSE OF DIAZEPAM GIVEN BY HIS MOTHER DID NOT BREAK THE SEIZURE. HE WAS TAKEN TO AN EMERGENCY CENTER FOR EVALUATION AND AED ADMINISTRATION. HIS SEIZURE APPEARED TO BREAK AND HE WAS TRANSFERRED TO THE HOSPITAL THE SAME DAY WHERE HE WAS ADMITTED. HE DEVELOPED SEIZURE ACTIVITY AND WAS TREATED WITH MULTIPLE MEDICATIONS. THE SEIZURES SEEMED TO COME UNDER CONTROL. AFTER NEUROLOGICAL EVALUATION, HE WAS TRANSFERRED TO THE PICU. THE ADMITTING ASSESSMENT WAS THAT HE WAS FOUND TO BE HYPOGLYCEMIC. THE SEIZURES CONTINUED TO BE TREATED WITH GLUCOSE AND AEDS. HE SEEMS TO STOP HAVING CONVULSIONS, BUT WAS IN A PROLONGED POSTICTAL STATE AND SUBCLINICAL SEIZURE ACTIVITY COULD NOT BE RULED OUT. VIDEO EEG CONFIRMED THE ACTIVITY. THE PATIENT DEVELOPED MULTIORGAN SYSTEM DYSFUNCTION AND SHOCK. AN INTERVAL CT SCAN INDICATED WORSENING GLOBAL CEREBRAL EDEMA WHICH WAS THOUGHT LIKELY RELATED TO PROLONGED SEIZURE ACTIVITY, PERHAPS AGGRAVATED TO SOME DEGREE BY HYPOXEMIA AND HYPOGLYCEMIA. THE TREATMENTS FOR THE MULTIORGAN SYSTEM DYSFUNCTION INCLUDED EPINEPHRINE AND VASOPRESSIN TO SUPPORT CARDIAC FUNCTION, FFP, CRYOPRECIPITATE AND PLATELETS FOR COAGULOPATHY WITH ELEVATED PTT AND LOW FIBRINOGEN. MRI SHOWED EVIDENCE CONSISTENT WITH HYPOXIC CEREBRAL EDEMA. THE PATIENT¿S RESPIRATORY STATUS DETERIORATED AND HE REQUIRED TREATMENT WITH MECHANICAL VENTILATION. OVERNIGHT BETWEEN (B)(6), HE CONTINUED TO HAVE PROBLEMS WITH SHOCK AND CIRCULATORY FAILURE AS WELL AS WORSENING RESPIRATORY FAILURE AND SEEMED TO PROGRESS TO NEUROLOGICAL BRAIN DEATH. ON 10/17, AN EVALUATION REVEALED THAT BRAIN DEATH INCLUDING THE BRAINSTEM HAD OCCURRED. DEATH WAS DECLARED AT 11:51 ON (B)(6) 2012. THE CLINICAL CAUSE OF DEATH WAS A PROLONGED SEIZURE LEADING TO HYPOXIC ISCHEMIC BRAIN INJURY AND PROGRESSION TO BRAIN DEATH. THE PROLONGED SEIZURE WAS ALSO REFERRED TO AS STATUS EPILEPTICUS EARLIER IN THE NOTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405929 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 1970

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Death