BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2930248 · Received January 25, 2013

    Report

    Report Number
    1644487-2013-00217
    Event Type
    Death
    Date Received
    January 25, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 27, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HOLD. NG 1/2/13.THE REPORTER INDICATED THAT A VNS PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 DUE TO SEIZURES, WHERE THE PATIENT LATER EXHIBITED ADDITIONAL ADVERSE EVENTS WHICH INCLUDED ASYSTOLE, BRADYCARDIA, ASPIRATION, AND COUGHING. THE PATIENT LATTER DIED ON (B)(6) 2012 AT 4AM IN THE HOSPITAL DUE TO CARDIAC ARREST, AND THE DEATH WAS WITNESSED. X-RAYS REVIEWED BY THE MANUFACTURER ON (B)(6) 2013 NOTED NO ANOMALIES. THE REPORTER LATER STATED THAT THE COUGHING AND ASPIRATION WERE RELATED TO PNEUMONIA, AND THAT THE INCREASE IN SEIZURES WAS RELATED TO THE FACT THAT THE PATIENT IS KNOWN FOR "PERIODIC FLURRIES OF SEIZURES." AFTER THE PATIENT WAS HOSPITALIZED THE VNS WAS DISABLED USING THE MAGNET, AND BRADYCARDIA RECOVERY WAS NOTED. THE REPORTER ALSO STATED THAT THE PATIENT HAD FOUR HEART ATTACKS BEFORE THE VNS WAS IMPLANTED. THE CONCURRENT ILLNESSES/DISEASES INCLUDE PNEUMONIA, DEVELOPMENTAL DELAY, HEART ATTACKS (X4), STROKE, LUNG CANCER, CEREBRAL PALSY, ABSENT CORPUS CALLOSUM, AND MENTAL RETARDATION. IT WAS NOT KNOWN TO THE REPORTER IF THE VNS WAS EXPLANTED AFTER DEATH. IT IS NOT KNOWN IF AN AUTOPSY WAS PERFORMED. THE REPORTER STATED THAT HE TRIED TO OBTAIN INFORMATION FROM THE HOSPITAL STAFF THAT REGARDING THE PATIENT'S CONDITION, BUT THEY DID NOT RESPOND. THE PHYSICIAN STATED THAT THE PATIENT WAS VERY ILL WHO WAS IN HIS 20'S WITH A "5 YEAR-OLD BODY", AND HAD BAD SEIZURES, NO CORPUS CALLOSUM, SUFFERED A STROKE AND HAD A PEG TUBE ALL BEFORE THE VNS WAS IMPLANTED. THE PATIENT'S MEDICATIONS WERE CHANGED ON (B)(6)2012 TO COMPENSATE FOR THE VNS BEING DISABLED WITH THE MAGNET. PER THE REPORTER, THE RELATIONSHIP OF THE DEATH TO THE VNS IS UNKNOWN.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED INDICATING THAT THE IMPLANTED VNS PRODUCTS WERE NOT EXPLANTED PRIOR TO THE FUNERAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35844 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201889

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death| H| R