BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3171020 · Received June 14, 2013

    Report

    Report Number
    1644487-2013-01792
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 20, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A VNS BATTERY REPLACEMENT ON (B)(6) 2013. IT WAS REPORTED THAT THIS REPLACEMENT WAS DUE TO END OF SERVICE; HOWEVER, THE DEVICE WAS INTERROGATED PRIOR TO SURGERY AND FOUND TO NOT BE AT END OF SERVICE. THE SURGEON STILL PERFORMED THE SURGERY ON THIS DATE AS THE PATIENT'S PARENTS SAID THAT THE PATIENT WAS NOT DOING AS WELL WITH THE VNS AS BEFORE, AND THEY BELIEVED THE BATTERY WAS DEAD. IT COULD NOT BE VERIFIED WHAT THE "NOT DOING AS WELL" REFERRED TO. FOLLOW UP WITH THE SURGEON'S OFFICE FOUND THAT THE PATIENT'S PARENTS HAD COME TO THEM TO GET THE DEVICE REPLACED AS THEY HAD BEEN TOLD BY THEIR TREATING VNS PHYSICIAN UPON INTERROGATION THAT THE DEVICE WAS AT END OF SERVICE. THE NURSE STATED THAT, PER THE PARENTS, THE PHYSICIAN ATTRIBUTED THE SEIZURE ACTIVITY TO THIS END OF SERVICE STATE. THE PATIENT'S DEVICE WAS INTERROGATED BY THE SURGEON'S OFFICE AND FOUND TO NOT BE AT END OF SERVICE; HOWEVER, THE PARENT'S WANTED THE DEVICE REPLACED ANYWAY. NO OTHER INFORMATION WAS PROVIDED, AS THE NURSE STATED THAT THIS WAS ALL THE INFORMATION THEY WERE HAD. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, THEY HAVE BEEN UNSUCCESSFUL. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE NEUROLOGIST'S OFFICE FOUND THAT THE DEVICE HAD BEEN INTERROGATED AND SEEN TO BE AT END OF LIFE. THE NURSE CONFIRMED THAT SHE SAW THIS MESSAGE DURING INTERROGATION AND STATED THAT THE PATIENT HAD BEEN REFERRED FOR SURGERY FOR THIS. HOWEVER, AN IMPLANT CARD WAS LATER RECEIVED WHICH INDICATES THE REPLACEMENT WAS DUE TO PROPHYLACTIC REASONS. THE NURSE CONFIRMED THAT THE PARENTS WERE REFERRING TO THE PATIENT'S SEIZURE FREQUENCY WHEN THEY STATED THAT THE PATIENT WAS NOT DOING AS WELL AS BEFORE. THE PATIENT HAS ALWAYS HAD A HIGH FREQUENCY OF SEIZURES, AND THIS INCREASE WAS THE SAME AS PRE-VNS BASELINES. WHEN ASKED ABOUT THE RELATION TO VNS, SHE STATED THAT IF THE PATIENT IS NOT RECEIVING ALL OR PART OF THE VNS STIMULATION, THEN THERE WOULD BE AN INCREASE IN SEIZURES. SHE STATED THAT IF THE PATIENT'S DEVICE WAS REPLACED, THEN THEY WILL NEED TO RE-TITRATE THE DEVICE TO EFFICACIOUS SETTINGS. IT WAS UNKNOWN WHEN THE INCREASE IN SEIZURES WAS FIRST OBSERVED. WHEN ASKED IF THE PATIENT HAS MULTIPLE SEIZURE TYPES, THE NURSE JUST STATED THAT THE PATIENT HAS INTRACTABLE EPILEPSY. NO PROGRAMMING OR MEDICATION CHANGES PRECEDED THE EVENT. NO PROGRAMMING AND DIAGNOSTIC INFORMATION WAS PROVIDED. NO OTHER INFORMATION WAS PROVIDED. THE EXPLANTED GENERATOR HAS BEEN DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270538 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2897

    Patients

    Seq Age Sex Outcome Treatment
    1 Other