BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3001934 · Received March 13, 2013

    Report

    Report Number
    1644487-2013-00689
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    January 1, 2012
    Report Date
    February 15, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. THE SEPTUM WAS NOT CORED, THUS ELIMINATING THE POSSIBILITY OF A POTENTIAL UNINTENDED ELECTRICAL CURRENT PATH THROUGH BODY FLUIDS. IN THE PRODUCT ANALYSIS LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ON (B)(6) 2013 CLINIC NOTES WERE RECEIVED FROM A VNS TREATING PHYSICIAN. REVIEW OF THE CLINIC NOTES DATED (B)(6) 2013 INDICATED THAT THE PATIENT HAS HAD INCREASED SEIZURE ACTIVITY IN THE PAST THREE MONTHS. THE PATIENT WAS NOTED TO BE HAVING REFRACTORY COMPLEX PARTIAL SEIZURES AND NOW NEEDS A BATTERY REPLACEMENT. THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT AND IT WAS STATED THAT THE PATIENT'S BATTERY IS DEAD. CLINIC NOTES DATED (B)(6) 2013 MENTION THAT THE PATIENT IS NOT CURRENTLY COMPLAINING OF ANY PINCHING OR PAIN FROM VNS THAT HE HAD IN THE PAST. THE PATIENT HAD REPORTED ON CLINIC NOTES DATED (B)(6) 2012 THAT "IT HURTS WHEN HE ROLLS OVER" AND HE WANTS HIS VNS REMOVED. THE CLINIC NOTES DATED (B)(6) 2012 STATED THAT THE PAINT HAS BEEN HAVING MULTIPLE SEIZURES ALL DAY; THE PATIENT HAD 7 SEIZURES BETWEEN 3:45PM AND 4:05PM. THE NURSE STATED THAT THERE HAVE BEEN NO MISSED DOSES AND NO NEW MEDICATIONS. THE CLINIC NOTES DATED (B)(6) 2012 STATE THAT THE PATIENT WAS SEEN FOR A FOLLOW-UP BECAUSE OF AN INCREASED NUMBER OF SPELLS. THE PATIENT DID HAVE AT LEAST 6 OF THOSE SEIZURES THAT MORNING, BUT THE PHYSICIAN FOUND THAT THE PATIENT WAS SPENDING MOST OF HIS NIGHTS AWAKE WATCHING TV OR PLAYING VIDEO GAMES. THE PHYSICIAN STATED THAT THE PATIENT HAS WORN HIS VNS OUT. THE CLINIC NOTES DATED (B)(6) 2012 INDICATED THAT THE PATIENT HAS PAIN WHEN LYING ON THE LEFT SIDE AT HIS VNS STIMULATOR SITE AND AGAIN THE PATIENT EXPRESSED DESIRE FOR ITS REMOVAL. ON (B)(6) 2012 THE PATIENT UNDERWENT A 4 DAY VIDEO EEG AS THE PATIENT RECENTLY STARTED HAVING DIFFERENT TYPE OF SPELLS. THE NEW SPELLS WERE DESCRIBED AS HUMMING, DROOLING, APHASIA, AND TREMBLING. THEY WERE NOTED TO LAST ABOUT 10 SECONDS, BUT CAN HAPPEN MULTIPLE TIMES A DAY. THE SPELLS WERE SUSPECTED TO BE BEHAVIORAL ESPECIALLY THAT CHANGING HIS SEIZURE MEDICATIONS WAS NOT HELPFUL. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013 AND IT WAS NOTED THAT THERE WAS NO END OF SERVICE WARNING UPON INTERROGATION IN PRE-OP. THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS ON (B)(6) 2013. IT WAS LATER REPORTED THAT THE REASON FOR GENERATOR REPLACEMENT WAS FOR PROPHYLACTIC REASONS. THE PHYSICIAN LATER REPORTED THAT THE INCREASED SEIZURES WERE FIRST OBSERVED AROUND (B)(6) 2012. THE PHYSICIAN STATED THAT THE PAIN THE PATIENT FEELS IS A "PINCHING" SENSATION IN THE VNS NECK SITE THAT OCCURS WITH STIMULATION. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED/CONTRIBUTED TO THE PAIN. NO FURTHER INFORMATION WAS PROVIDED FROM THE PHYSICIAN. PRODUCT ANALYSIS ON THE GENERATOR IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED. A BLC WAS PERFORMED WITH THE PROGRAMMING HISTORY AVAILABLE WHICH SHOWED 9.05 YEARS REMAINING UNTIL ERI=YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105075 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 012081

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other