BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2063789 · Received April 15, 2011

    Report

    Report Number
    1644487-2011-00794
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 15, 2017
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A VNS PATIENT THAT HE HAD BEEN IMPLANTED ORIGINALLY FOR A STUDY FOR MIGRAINE HEADACHES, BUT WAS SUBSEQUENTLY DISABLED IN 2004. THE PATIENT STATED HE HAD RECENTLY BEEN DIAGNOSED WITH GASTROPARESIS AND NOTED THAT DAMAGE TO THE VAGUS NERVE COULD BE A CAUSE. HE WAS DIAGNOSED WITH THIS BY HIS PRIMARY CARE PHYSICIAN AS HE HAD PERSISTENT ISSUES WITH VOMITING, NAUSEA, REFLUX, BLOATING, AND BURPING, WHICH WAS NOT RELATED TO THE VNS STIMULATION. THE PATIENT STATED HE HAD SOME NAUSEA AND VOMITING PRE-VNS ASSOCIATED WITH HIS MIGRAINES, BUT SINCE IMPLANT, HE FELT THEY HAD GOTTEN PROGRESSIVELY WORSE. THE PATIENT HAD SEEN A GASTROENTEROLOGIST FOR THESE ISSUES WHO RAN A "GET" TEST, WHICH "SHOWED SOME ISSUES"; HOWEVER, THE GASTROENTEROLOGIST DID NOT PERFORM THE DIAGNOSIS OF GASTROPARESIS BUT THE PRIMARY CARE PHYSICIAN. CONSEQUENTLY, HE WAS GOING TO REFER BACK TO THE GASTROENTEROLOGIST TO DISCUSS THE ISSUE. FOLLOW-UP OBTAINED FROM THE PATIENT INDICATED THAT THE GASTROENTEROLOGIST WAS CONSIDERING VNS STIMULATION AS A TREATMENT OPTION FOR THE GASTROPARESIS. THE PATIENT'S NEUROLOGIST DURING THE TIME OF HIS ORIGINAL STUDY WAS CONTACTED, BUT THE PATIENT WAS STATED TO HAVE NEVER REPORTED AND GASTRIC ISSUES TO HIM. THE NEUROLOGIST STATED HE BELIEVED THE EVENTS TO BE "RECENT". GOOD FAITH ATTEMPTS, TO DATE, FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 PULSE GENERATOR LYJ CYBERONICS INC 101 4678

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other