BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2212538 · Received August 16, 2011

    Report

    Report Number
    1644487-2011-01874
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    March 14, 2010
    Report Date
    July 20, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2011 CLINIC NOTES FROM A VNS TREATING PHYSICIAN WERE RECEIVED THROUGH CASE MANAGEMENT. REVIEW OF THE CLINIC NOTES DATED (B)(6) 2011, REVEALED THAT THE PATIENT HAS BEEN EXPERIENCING AN INCREASE IN SEIZURES FOR THE PAST SIX MONTHS TO A YEAR. THE PHYSICIAN REPORTED THAT AROUND (B)(6) 2010, THE PATIENT WAS ASSAULTED BY THEIR CAREGIVER AND RECEIVED SEVERAL BLOWS TO THE HEAD. THE PATIENT HAS EXPERIENCED INCREASED SEIZURES SINCE THE ASSAULT. IT IS UNKNOWN AT THIS TIME IF THE INCREASED IN SEIZURES FOR THE PAST SIX MONTHS TO A YEAR ARE DUE TO THE ASSAULT. THE PHYSICIAN REPORTED THAT THE PATIENT NEEDS A VNS BATTERY CHANGE BECAUSE THE DEVICE IS NEARING END OF SERVICE. CLINIC NOTES DATED (B)(6) 2011, REPORTED THAT SINCE THE PATIENT WAS BEATEN IN THE HEAD BY THEIR CAREGIVER IN (B)(6) 2010, THE PATIENT HAS BEEN HAVING EPISODES OF FALLING FORWARD OR GRAND MAL SEIZURES, AS WELL AS STARING. CLINIC NOTES DATED (B)(6) 2010, REPORT THAT THE PATIENT CONTINUES TO HAVE FREQUENT SEIZURE ACTIVITY. THE PHYSICIAN BELIEVES THAT HE WILL BE DUE FOR A BATTERY CHANGE IN THE NEXT SIX TO TWELVE MONTHS GIVEN THAT HIS VNS HAS BEEN PRESENT FOR 5 YEARS AT VERY HIGH SETTINGS. THE PATIENT WENT FOR BATTERY REPLACEMENT SURGERY ON (B)(6) 2011 AND DIAGNOSTICS PRIOR TO SURGERY REVEALED THAT THE PATIENT HAD HIGH LEAD IMPEDANCE. THE PATIENT WAS RESCHEDULED FOR A FULL REVISION SURGERY LATER IN SEPTEMBER. THE PHYSICIAN REPORTED THAT THEY WILL NOT HAVE X-RAYS PERFORMED SINCE THEY ARE DOING A FULL REVISION. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION ARE UNDERWAY BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. THE PATIENT'S PROGRAMMING HISTORY WAS REVIEWED AND THE PATIENT'S LAST SETTINGS ON (B)(6) 2010, WERE OUTPUT=1.75MA/FREQUENCY=30HZ/PULSE WIDTH=500USEC/ON TIME=14SEC/OFF TIME=0.5MIN/MAGNET OUTPUT=2MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=60SEC. A BATTERY LIFE CALCULATION WAS PERFORMED WITH THE PATIENT'S PROGRAMMING HISTORY AVAILABLE WHICH REVEALED NEGATIVE YEARS UNTIL ERI = YES. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT YET OCCURRED. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011, WHEN IT WAS DISCOVERED THAT THE VNS PATIENT HAD A FULL REVISION SURGERY ON (B)(6) 2011. THE EXPLANTED GENERATOR AND LEAD WERE DISCARDED BY THE HOSPITAL. THE MANUFACTURER'S CONSULTANT REPORTED THAT THE PHYSICIAN BELIEVES THE PATIENT'S INCREASE IN SEIZURES, CHANGE IN SEIZURE PATTERN, AND INSOMNIA WERE NOT RELATED TO VNS. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1391

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention