BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3123801 · Received May 22, 2013

    Report

    Report Number
    1644487-2013-01538
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    February 1, 2012
    Report Date
    May 1, 2013
    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

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

    Additional Manufacturer Narrative · 1

    THE INCREASED SEIZURES IS CHARACTERIZED AS AN ADVERSE EVENT BECAUSE MEDICAL INTERVENTION WAS TAKEN BY CHANGING THE SIGNAL OFF-TIME OF THE VNS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE NEUROLOGIST REPORTING THAT THE INCREASE IN SEIZURES THAT FIRST BEGAN IN (B)(6) 2012 WAS ABOVE PRE-VNS SEIZURE FREQUENCY LEVEL. HE THOUGHT THE INCREASED SEIZURES MAY HAVE BEEN RELATED TO A ¿FADING GENERATOR,¿ BUT HE IS NOT CERTAIN. DECREASING THE SIGNAL OFF TIME TO 1.1MIN HELPED THE PATIENT A LOT. THE NEUROLOGIST WAS NOT SURE IF THERE WERE ANY CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDE THE ONSET OF THE INCREASED SEIZURES. THE PATIENT WAS REFERRED FOR A GENERATOR REPLACEMENT. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    REVIEW OF THE PATIENT¿S CLINIC NOTES DATED (B)(6) 2012 REVEALED THAT THE PATIENT AND HIS WIFE REPORTED THAT THE PATIENT SEEMED TO BE HAVING MORE LIGHT SEIZURES. THEY WERE CHARACTERIZED BY PERIODS WHEREIN HE WOULD HAVE STARING IN SPACE AND TWITCHING OF HIS EYES AND FACE WHICH WOULD LAST FOR A SECOND OR SO AND THEN WOULD GO AWAY SPONTANEOUSLY. HOWEVER, HE HAD A "BIG ONE" SOMETIME AROUND (B)(6) 2012. AT THAT TIME, HE HAD A LIGHT ONE AND THEN HE FELL DOWN AND JERKED ALL OVER FOR AN UNKNOWN PERIOD OF TIME. THE PATIENT HAD NOT HAD ANY MORE SINCE THEN AS OF (B)(6) 2012. THE SIGNAL OFF-TIME WAS INTENDED TO BE DECREASED FROM 1.8MIN TO 1.1MIN TO SEE IF THE SETTING CHANGE WOULD HELP THE PATIENT¿S SEIZURE FREQUENCY DECREASE. NO OTHER CHANGES WERE MADE. THE DEVICE SHOWED THAT IT WAS NOT NEAR END OF SERVICE. (PER NOTES ON (B)(6) 2012, THE OFF-TIME WAS NOT CHANGED TO 1.1MIN AS INTENDED WHICH IS CAPTURED IN MFG REPORT NUMBER: 1644487-2013-01537.) PER NOTES ON (B)(6) 2012, THE PATIENT HAD DONE WELL, AND HAD NO SEIZURES SINCE (B)(6) 2012. ON THE PREVIOUS VISIT ON (B)(6) 2011, THE OUTPUT CURRENT WAS INCREASED FROM 2.75MA TO 3.0MA. MEDICATIONS WERE NOT CHANGED. ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS ALSO OBSERVED IN PROGRAMMING HISTORY THAT UPON INITIAL INTERROGATION ON (B)(6) 2013, THE OUTPUT CURRENTS WERE SET TO 0 MA AND NEOS=YES. THE PREVIOUS DATE ON (B)(6) 2012, THE DEVICE WAS PROGRAMMED TO 3.0 MA/2.75 MA. IT APPEARS LIKELY THAT THE DEVICE REACHED END OF SERVICE (PULSE DISABLED) ON (B)(6) 2013 EVEN THOUGH THE INTERROGATION SHOWS NEOS=YES, AS THE DRAIN ON THE BATTERY DECREASED AT PULSE DISABLED CONDITION UNTIL THE DEVICE WAS INTERROGATED. THE BATTERY LIKELY THEN KICKED BACK TO SHOW NEOS CONDITION. ADDITIONALLY INFORMATION WAS RECEIVED FROM THE PHYSICIAN THAT IN (B)(6) 2012 NOTES, THE DEVICE WAS "WORKING FINE" AND DID NOT SHOW NEOS. HE DID NOT INTERROGATE THE DEVICE AGAIN UNTIL (B)(6) 2013 AT WHICH TIME IT WAS AT NEOS. THE PATIENT NEVER HAD ANY PROBLEMS AND NO PATIENT ADVERSE EVENTS WERE REPORTED. THE PATIENT WAS DOING WELL. THE PATIENT HAD GENERATOR REPLACEMENT ON (B)(6) 2013. PER HOSPITAL POLICY, THEY DESTROY THE EXPLANTED GENERATORS AFTER SURGERY SO THE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225915 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201739

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention