BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2480496 · Received March 6, 2012

    Report

    Report Number
    1644487-2012-00609
    Event Type
    Death
    Date Received
    March 6, 2012
    Date of Event
    December 14, 2010
    Report Date
    February 8, 2012
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER, CORRECTED DATA: INADVERTENTLY NOT PROVIDED IN FOLLOW-UP REPORT #02. THE RECEIVED DATE FOR FOLLOW-UP REPORT #02 WAS 03/03/2016.

    Description of Event or Problem · 1

    THE PATIENT'S DEATH CERTIFICATE WAS OBTAINED AND REVIEWED. THE CAUSE OF DEATH WAS ASPIRATION WITH RESPIRATORY ARREST ((B)(6)) AND SEIZURE DISORDER ((B)(6)). OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO DEATH BUT NOT RESULTING IN THE UNDERLYING CAUSE OF DEATH WERE MENTAL RETARDATION AND SPASTIC QUADRIPLEGIA. AN AUTOPSY WAS NOT PERFORMED, AND THE MANNER OF DEATH WAS NATURAL. THE PATIENT WAS CREMATED. AS THE CAUSE OF DEATH WAS ASPIRATION, SUDEP IS NO LONGER SUSPECTED AS A CAUSE OF DEATH. MANUFACTURER FOLLOW-UP WITH THE FUNERAL HOME REVEALED THE VNS WAS EXPLANTED PRIOR TO THE CREMATION AND GIVEN TO A DISPOSAL COMPANY.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT HAD DIED. THE CIRCUMSTANCES OF THE DEATH WERE DESCRIBED AS: "DURING NIGHT TIME BED CHECKS THE DIRECT SUPPORT STAFF PERSON WENT IN AND CHECKED ON HIM AND FOUND HIM. SHE CALLED THE NURSE WHO STARTED CPR AND IT WAS CALLED WHEN THE EMS ARRIVED AND TOOK OVER. PRONOUNCED BY THE CORONER"; THE PATIENT LIVED IN AN ASSISTED-CARE FACILITY, INDICATING HE WAS IN A REASONABLE STATE OF HEALTH. THE PATIENT WAS COMPLIANT WITH HIS MEDICATIONS, AND HAD NO HISTORY OF CARDIAC OR RESPIRATORY PROBLEMS, OR SUBSTANCE ABUSE. THE PATIENT WAS FOUND UNRESPONSIVE DURING A NIGHT CHECK AT THE FACILITY. IT IS NOT SPECIFIED THE PATIENT WAS IN HIS BED, BUT THIS IS LIKELY AS IT WAS NIGHTTIME. THE DEATH WAS ALSO NOT WITNESSED. THE PATIENT HAD A HISTORY OF NOCTURNAL SEIZURES BUT NO FEBRILE SEIZURES. VNS PROVIDED A 25% REDUCTION IN SEIZURES. THE PATIENT WAS RECEIVING VNS THERAPY AT THE TIME OF DEATH, BUT VNS SETTINGS WERE NOT PROVIDED. THE AVAILABLE INFORMATION SUGGESTS THE DEATH IS PROBABLE SUDEP. PER THE REPORTER, THE DEATH WAS UNRELATED TO THE VNS. ATTEMPTS FOR THE DEATH CERTIFICATE AND DISPOSITION OF THE VNS DEVICE ARE IN PROGRESS.

    Description of Event or Problem · 1

    CAUSE OF DEATH INFORMATION OBTAINED FROM THE (B)(6) WAS REVIEWED BY THE MANUFACTURER WHICH INDICATED THAT THE PATIENT HAD DIED ON (B)(6) 2010 DUE TO CAUSES OF RESPIRATORY ARREST; OTHER AND UNSPECIFIED CONVULSIONS; FOREIGN BODY IN RESPIRATORY TRACT, PART UNSPECIFIED; INHALATION AND INGESTION OF OTHER OBJECTS CAUSING OBSTRUCTION OF RESPIRATORY TRACT. OTHER CONTRIBUTING FACTORS WERE PROVIDED AS UNSPECIFIED MENTAL RETARDATION; SPASTIC TETRAPLEGIA; OSTEOPOROSIS, UNSPECIFIED. A SUDEP (SUDDEN UNEXPECTED DEATH IN EPILEPSY) EVALUATION WAS PERFORMED WHICH DETERMINED THAT THE DEATH MET CRITERIA FOR CLASSIFICATION OF PROBABLE SUDEP. THERE IS NO ALLEGATION OR OTHER INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 017112

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death