BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3121681 · Received May 21, 2013

    Report

    Report Number
    1644487-2013-01482
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 29, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INADVERTENTLY DID NOT REPORT THE LAST AVAILABLE DIAGNOSTIC RESULTS. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE SURGEON¿S OFFICE REPORTED THAT THE PATIENT WAS BEING SCHEDULED FOR VNS GENERATOR AND LEAD REPLACEMENT. IT WAS INITIALLY REPORTED THAT THE REASON FOR THIS REPLACEMENT IS THAT PER THE CAREGIVER, USUALLY WHEN THE PATIENT SWIPES THE MAGNET, THE PATIENT COUGHS AND CHOKES, BUT IT WAS NO LONGER OCCURRING. FOLLOW-UP WITH THE SURGEON¿S OFFICE REVEALED THAT THE PATIENT COULD NO LONGER PERCEIVE THE STIMULATION ABOUT ONE WEEK PRIOR TO THE PATIENT¿S APPOINTMENT WITH THE NEUROLOGIST ON (B)(6) 2013. THE PATIENT NORMALLY COUGHED AND CHOKED WITH NORMAL MODE STIMULATION AS WELL. NO CAUSAL OR CONTRIBUTORY PROGRAMMING OR MEDICATION CHANGES PRECEDED THE ONSET OF THE STIMULATION NO LONGER PERCEIVED, AND NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CONTRIBUTED TO THE EVENTS. THE PATIENT WAS REFERRED FOR SURGERY AS A RESULT. CLINIC NOTES DATED (B)(6) 2013 WERE LATER RECEIVED BY THE SURGEON¿S OFFICE. THE PHYSICIAN NOTED THAT THE CAREGIVERS NOTICED ABOUT A WEEK AGO THAT ¿AFTER HE HAD A SEIZURE WHEN THEY SWIPED HIS MAGNET THE PATIENT DID NOT CHOKE AFTERWARDS. HE NORMALLY WOULD CHOKE AND GAG AFTERWARDS, AND SOMETIMES EVEN HIS SATURATIONS WOULD DROP, AND IT DID HAPPEN, BUT IT HAPPENED SEVERAL MINUTES AFTER THEY DID IT WHICH THEY THOUGHT WAS UNUSUAL.¿ THE CAREGIVERS REPORTED TO THE SURGEON THAT THE NEUROLOGIST SAW THE SURGEON ON (B)(6) 2013 AND TOLD THEM THE ¿LEADS WERE MALFUNCTIONING.¿ THEY HAVE NOT NOTICED ANY CHANGE IN THE PATIENT¿S SEIZURES. THE PATIENT HAS BEEN SENSITIVE TO THE DEVICE SETTINGS SINCE GENERATOR REPLACEMENT ON (B)(6) 2012, AND PER THE SURGEON, IT HAS BEEN ON THE LOWEST SETTING (0.25MA). THE CAREGIVERS THOUGHT THE PATIENT WAS IN PAIN THOUGH BECAUSE HE WOULD INTERMITTENTLY CRY OUT IN PAIN, AND THEY WERE CONCERNED THAT IT MIGHT BE HURTING HIM, AND THE NEUROLOGIST REPORTEDLY TOLD THEM THAT IT IS POSSIBLE WHICH THE SURGEON REPORTED SHE AGREED. OTHERWISE, THE NOTES INDICATED THE PATIENT WAS UNCHANGED. THE GENERATOR WAS TURNED OFF, BUT THE MAGNET MODE WAS LEFT ON AT 0.75 MA. THE SURGEON INDICATED THAT SHE WAS NOT SURE THAT THE MAGNET WOULD STILL WORK. IN THE SURGEON¿S OPINION, THE PATIENT WAS PROBABLY USING THE MAGNET MORE THAN THEY REALIZED, AND SHE INDICATED THAT THEY MAY FIND THAT THE PATIENT¿S SEIZURE INCREASE WITH THE DEVICE TURNED OFF BUT SHE WAS NOT SURE IT WAS AT A THERAPEUTIC LEVEL ANYWAY SINCE IT WAS ONLY AT 0.25MA. THE PATIENT HAS A G-TUBE. THE SURGEON RECOMMENDED TO HAVE BOTH THE GENERATOR AND LEAD REPLACED, BUT SINCE THE GENERATOR WAS NOT NEARING END OF SERVICE, SHE THOUGHT IT WAS REASONABLE TO ONLY REPLACE THE LEAD. AN IMPLANT CARD WAS LATER RECEIVED BY THE MANUFACTURER WHICH REPORTED THAT THE PATIENT HAD LEAD REPLACEMENT ON (B)(6) 2013 DUE TO ¿LEAD DISCONTINUITY.¿ THE GENERATOR WAS NOT REPLACED. ATTEMPTS FOR PRODUCT RETURN ARE UNDERWAY, BUT THE PRODUCT HAS NOT BEEN RECEIVED TO DATE. ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE NEUROLOGIST¿S OFFICE HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE LEAD WAS DISCARDED AFTER SURGERY, SO PRODUCT RETURN IS UNABLE TO BE PERFORMED. THE NURSE AT THE NEUROLOGIST¿S OFFICE REPORTED THAT THE PATIENT HAS NOT BEEN SEEN RECENTLY, SO SHE WAS UNABLE TO INDICATE WHETHER THE PATIENT'S SYMPTOMS HAVE IMPROVED. THE NURSE WAS NOT AWARE THAT THE PATIENT HAD SURGERY TO DATE. DIAGNOSTICS WERE PERFORMED ON THE PATIENT¿S VNS PRIOR TO REFERRING HIM TO NEUROSURGERY WHICH IS HOW SHE KNEW THAT ¿THE LEAD WAS NOT WORKING." HOWEVER, THE NURSE DID NOT REMEMBER THE EXACT MESSAGE OR DIAGNOSTIC RESULTS IMPEDANCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224456 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 009541

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention