BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3162733 · Received June 11, 2013

    Report

    Report Number
    1644487-2013-01739
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 17, 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

    ANALYSIS OF PROGRAMMING HISTORY.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED AND SEEN FOR FOLLOW-UP. THE PATIENT'S GENERATOR WAS ABLE TO BE INTERROGATED; HOWEVER, IT WAS REPORTED THAT THE SYSTEM "STALLED" PRIOR TO THE PARAMETER DISPLAY SCREEN. THE PATIENT LEFT THE PHYSICIAN'S OFFICE PRIOR TO PERFORMING TROUBLESHOOTING. IT WAS REPORTED THAT THE PATIENT LATER CAME BACK TO THE PHYSICIAN'S OFFICE AND THAT THE DEVICE WAS ABLE TO BE INTERROGATED; HOWEVER, THAT THE DEVICE PULSE WIDTH WAS DIFFERENT FROM WHAT IT WAS PREVIOUSLY PROGRAMMED TO. THE PHYSICIAN INDICATED THAT THE PATIENT RECENTLY UNDERWENT SEPTUM SURGERY AND THE PHYSICIAN BELIEVES THAT THE DEVICE MAY HAVE BEEN PROGRAMMED OFF FOR THE SURGERY AND THAT WHEN IT WAS PROGRAMMED BACK ON THE SETTINGS MAY HAVE BEEN CHANGED. THE PATIENT WAS UNABLE TO FEEL THE SETTINGS AT THE 0.25MA; HOWEVER, THE PHYSICIAN INCREASED THE OUTPUT CURRENT TO 0.5MA AND THE PATIENT REPORTED THAT SHE WAS ABLE TO FEEL THE DEVICE STIMULATION. THE PHYSICIAN BELIEVED THAT THE PATIENT'S INCREASE IN DEPRESSION WAS RELATED TO THE DEVICE SETTINGS. THE PHYSICIAN PLANNED TO FOLLOW-UP ON IF THE CHANGE IN DEVICE SETTINGS IMPROVES THE PATIENT'S DEPRESSION.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE COULD NOT BE COMMUNICATED WITH ON (B)(6) 2013 AND THAT THE PHYSICIAN BELIEVES THE DEVICE IS AT END OF SERVICE. THE PHYSICIAN STATED THAT PRIOR TO THE PATIENT RECEIVING VNS, THE PATIENT HAD SEVERE MIGRAINES AND A STROKE. THE STROKE CAUSED HER TO HAVE SLURRED SPEECH AND SHE WAS UNABLE TO WALK UPRIGHT. AFTER RECEIVING VNS, THE PATIENT WAS REPORTED TO HAVE IMPROVED SPEECH, NO MIGRAINES, AND WAS ABLE TO WALK UPRIGHT WITH NO ASSISTANCE. THE PHYSICIAN HOWEVER REPORTED THAT THE PATIENT¿S MIGRAINES AND SLURRED SPEECH HAVE RETURNED AND THE PATIENT WANTS TO HAVE THE VNS REPLACED BEFORE ALL HER PRE-VNS SYMPTOMS RETURN. THE PHYSICIAN ALSO REPORTED THAT NOW SINCE THE BATTERY IS DEPLETED, HER DEPRESSION IS RETURNING. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 8.83 YEARS REMAINING UNTIL ERI=YES. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO BE SEEN THAT DAY BUT CANCELLED HER APPOINTMENT. THE PHYSICIAN¿S PROGRAMMING SYSTEM WAS CHECKED AND IT WAS FOUND THAT THE 9V BATTERY IN THE WAND WAS DEAD, AFTER REPLACING IT THE PROGRAMMING SYSTEM WAS CONFIRMED TO BE FUNCTIONING PROPERLY. THE PHYSICIAN MENTIONED THAT WHEN THE PATIENT WAS LAST SEEN, WHEN HER DEVICE WAS UNABLE TO BE INTERROGATED, THE PATIENT HAD REPORTED AN INCREASE IN DEPRESSION AND INABILITY TO PERCEIVE STIMULATION. THE PHYSICIAN BELIEVES THAT THE BATTERY MAY BE DEAD AS A RESULT OF ALL OF THESE EVENTS; HOWEVER SHE WAS GOING TO HAVE THE PATIENT COME IN TO CHECK HER DEVICE AGAIN AND TO CONFIRM IF THE GENERATOR NEEDS REPLACING. THE PHYSICIAN¿S OFFICE WAS CONTACTED TO SEE IF THE PATIENT HAS BEEN SEEN AGAIN BUT NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE PHYSICIAN. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    REVIEW OF AVAILABLE PROGRAMMING HISTORY ON (B)(6) 2014 SHOWED THAT THE PATIENT¿S DEVICE WAS PROGRAMMED ON (B)(6) 2010 TO THE SETTINGS THAT THE PHYSICIAN REPORTED AS BEING DIFFERENT FROM WHAT SHE BELIEVED. FURTHERMORE, REVIEW OF THE FAX RECEIVED FROM THE PHYSICIAN ON (B)(6) 2013 SHOWS THAT THE PHYSICIAN REPORTED THESE SAME SETTINGS. IT APPEARS THAT DEVICE SETTINGS WERE UNCHANGED FROM (B)(6) 2010. THE REPORTED ADVERSE EVENTS MAY BE RELATED TO THE PATIENT BECOMING ACCUSTOMED TO THE THERAPY LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263326 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 013894

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other