BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3232880 · Received July 18, 2013

    Report

    Report Number
    1644487-2013-02167
    Event Type
    Death
    Date Received
    July 18, 2013
    Date of Event
    May 22, 2010
    Report Date
    June 24, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAUSE OF DEATH WAS DUE TO A SUBCLAVIAN CLOT AND THAT THE PATIENT EXPERIENCED A SWALLOWING DISORDER AND SEIZURES. THE HOSPITAL MEDICAL RECORDS INDICATED THAT THE PATIENT WAS HOSPITALIZED PRIOR TO THE PATIENT'S DEATH FROM (B)(6) 2010 AND WAS DIAGNOSED WITH DVTS IN THE UPPER ARMS, RESPIRATORY DISTRESS, SEIZURE DISORDER, DYSPNEA, ALTERED MENTAL STATUS, GASTRO-ESOPHAGEAL REFLUX DISORDER AND PARANOID SCHIZOPHRENIA. IT WAS REPORTED THAT THE PATIENT WAS IN HOSPICE CARE AT THE TIME OF HIS DEATH, BUT THAT THERE ARE NO RECORDS IN THE MEDICAL RECORDS OFFICE FROM THAT TIME. IT WAS REPORTED THAT THE PATIENT WAS BURIED AND WAS MOST PROBABLY BURIED WITH THE VNS STILL IMPLANTED. IT WAS REPORTED THAT THE VNS HELPED THE PATIENT'S SEIZURES. ADDITIONAL HOSPITAL NOTES WERE RECEIVED FROM THE HOSPITALIZATION PRIOR TO DEATH INDICATING THAT THE PATIENT WAS OBSERVED TO HAVE STOPPED BREATHING AND WAS PRONOUNCED DEATH ON (B)(6) 2010. IT WAS NOTED THAT THE OVERALL CLINICAL IMPRESSION WAS THAT THE PATIENT HAD RESPIRATORY FAILURE AND LACTIC ACIDOSIS SECONDARY TO RECURRENT ASPIRATION PNEUMONIA. THE DEATH CERTIFICATE LISTED SEIZURE DISORDER AS THE CAUSE OF DEATH DUE TO (OR AS A CONSEQUENCE OF) SWALLOWING DISORDER WITH ASPIRATION, DUE TO (OR AS A CONSEQUENCE OF) SUBCLAVIAN VEIN THROMBOSIS. THE MANNER OF DEATH WAS LISTED AS NATURAL. NO AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TREATING VNS PHYSICIAN'S OFFICE HAD NOT SEEN THE PATIENT SINCE 2010 AND HAD NOT FUTURE APPOINTMENT. UPON REVIEW OF THE INTERNET, THE PATIENT'S OBITUARY WAS FOUND WHICH REPORTED THE PATIENT PASSED ON (B)(6) 2010. REVIEW OF THE COMPANY PROGRAMMING HISTORY DATABASE SHOWS THAT THE TREATING PHYSICIAN PROGRAMMED THE PATIENT'S DEVICE ON (B)(6) 2010 AND INCREASED THE OUTPUT CURRENT AT THAT TIME. ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE. FOLLOW-UP WITH THE FUNERAL HOME REVEALED THAT IT IS NOT BELIEVED THAT THE VNS DEVICES WERE EXPLANTED PRIOR TO BURIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334203 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 012303

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death