BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2081448 · Received April 20, 2011

    Report

    Report Number
    1644487-2011-00855
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROLOGIST VIA CLINIC NOTES THAT HE WAS UNABLE TO INTERROGATE THE VAGUS NERVE STIMULATOR (VNS) DEVICE DUE TO "SOME TECHNICAL DIFFICULTIES." MANUFACTURER'S REPRESENTATIVE VISITED PHYSICIAN'S OFFICE AND IDENTIFIED THAT HIS VNS SYSTEM WAS WORKING FINE AND DID NOT IDENTIFY ANY ISSUES WITH THE PROGRAMMING HISTORY. ACCORDING TO PT'S CAREGIVER (I.E. FATHER), PT'S VOICE STILL CHANGES WHICH INDICATES THAT THE DEVICE WORKS. PT'S GRANDMOTHER STATED THAT PT HAD SMALL SEIZURES BUT HER FATHER DISPUTED IT. GOOD FAITH ATTEMPTS TO OBTAIN MORE INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200939

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR