BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3943667 · Received July 18, 2014

    Report

    Report Number
    1644487-2014-01829
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    July 22, 2012
    Report Date
    June 24, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    THE PATIENT¿S OBITUARY WAS LOCATED AND THE DATE OF DEATH WAS OBTAINED. IN ADDITION, INFORMATION FROM THE FACILITY WHERE THE PATIENT PASSED AWAY WAS ALSO RECEIVED. THE PATIENT HAD SEVERAL COMORBIDITIES THAT CONTRIBUTED TO THE DEATH. THE MOST SIGNIFICANT OF THESE INITIALLY WAS A BOWEL OBSTRUCTION. THE PATIENT HAD RECENTLY UNDERWENT LYSIS OF ADHESIONS, AN APPENDECTOMY, ENTEROTOMY, AND REMOVAL OF FOREIGN BODY WITH DECOMPRESSION OF THE SMALL INTESTINE AT A DIFFERENT HOSPITAL. THE PATIENT WAS KEPT SEDATED AND ON INTUBATION FOLLOWING THE PROCEDURE DUE TO ACUTE RESPIRATORY FAILURE. THERE WERE ALSO COMPLICATIONS DUE TO SEVERE PROTEIN CALORIE MALNUTRITION. THE PATIENT WAS TRANSFERRED TO SELECT SPECIALTY ON (B)(6) 2012 ON VENTILATOR SUPPORT. DESPITE EXTENSIVE EFFORTS BY THE STAFF TO TREAT THE PATIENT¿S ANASARCA, SEVERE HYPONATREMIA, AND HYPOTHERMIA, THE PATIENT COULD NOT BE WEANED FROM THE VENTILATOR. THEY HAD EVEN SHOWN INCREASED SEIZURES AT A WEANING ATTEMPT PRIOR TO TRANSFER. THE PATIENT¿S FAMILY DECIDED NOT TO PURSUE ANY AGGRESSIVE MEASURES FOR TREATMENT DUE TO THE PATIENT¿S COMPROMISED CONDITION AND THE PATIENT WAS DISCONTINUED FROM HIS NEO-SYNEPHRINE AND DOPAMINE DRIP. THE PATIENT WAS THEN PRONOUNCED DEAD SHORTLY THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421878 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2574

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death