BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3222552 · Received July 12, 2013

    Report

    Report Number
    1644487-2013-02085
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED DEVICE HISTORY RECORDS. REVIEW OF THE GENERATOR MANUFACTURING HISTORY RECORDS CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE PATIENT'S DEVICE WAS ABLE TO BE INTERROGATED AND THAT THE BATTERY LIFE INDICATOR SHOWED ROUGHLY 25% LEFT, IFI = NO. THE PHYSICIAN REPORTED THAT THE PATIENT'S DEVICE WAS NOT DISABLED AND THAT THE PATIENT WAS STILL RECEIVING STIMULATION. THE PHYSICIAN INDICATED THAT THE PATIENT'S SEIZURES NEVER SEEMED TO LESSEN WITH VNS, AND NO REPLACEMENT SURGERY HAS BEEN PLANNED. THE PHYSICIAN INDICATED THAT THE PATIENT'S SEIZURES WERE THE SAME BEFORE VNS AND THE PATIENT'S FAMILY IS ELECTING TO NOT HAVE THE DEVICE REIMPLANTED AS THEY FEEL VNS HAS NOT POSITIVELY IMPACTED THE PATIENT'S SEIZURE CONTROL.

    Description of Event or Problem · 1

    A NEUROLOGIST¿S OFFICE REPORTED THAT THE PATIENT WAS RECENTLY SEEN IN THE CLINIC, AND THE PATIENT'S DEVICE WAS NON-COMMUNICATIVE. AT THE TIME OF THE REPORT, THE PATIENT WAS NO LONGER IN THE OFFICE. ANOTHER PATIENT¿S DEVICE WAS RECENTLY PROGRAMMED LAST WEEK WITH THE SAME PROGRAMMING SYSTEM SUCCESSFULLY. THE PROGRAMMING SYSTEM¿S WAND WAS RULED OUT AS A POTENTIAL CAUSE, AND EMI WAS REPORTED TO NOT BE SIGNIFICANT IN THE ROOM AT THE TIME OF INTERROGATION. THE PROGRAMING COMPUTER WAS FULLY CHARGED, AND THE COMPUTER WAS NOT PLUGGED INTO THE WALL OUTLET. THE DEMIPULSE GENERATOR IS EXPECTED TO BE ABLE TO INTERROGATED AT ANY BATTERY STATUS LEVEL. THE COMPANY REPRESENTATIVE WENT TO THE OFFICE TO TROUBLESHOOT THE PROGRAMMING SYSTEM, AND THE PROGRAMMING SYSTEM WAS FUNCTIONING PROPERLY. INITIALLY, THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT, BUT LATER INFORMATION WAS RECEIVED THAT THE SURGERY IS ON HOLD BECAUSE THE PATIENT¿S PARENTS WANT TO DISCUSS THE SAFETY OF THE VNS DEVICE BEING OFF. FOLLOW-UP WITH THE PATIENT¿S PRIMARY VNS TREATING PHYSICIAN REVEALED THE PATIENT IS CURRENTLY TAKING ORAL ANTI-SEIZURE MEDICATIONS FOR SEIZURE PRECAUTION AND TO PRECLUDE SERIOUS INJURY. THE PATIENT IS SCHEDULED TO SEE THE SURGEON, BUT THE CONSULT HAS NOT OCCURRED TO DATE. IT IS STILL UNKNOWN WHY THE DEVICE COULD NOT BE INTERROGATED. IT COULD HAVE BEEN RELATED TO WAND POSITIONING, EMI, ETC..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323959 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2160

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR