BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 3840370 · Received May 30, 2014

    Report

    Report Number
    1644487-2014-01382
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 13, 2014
    Report Date
    May 5, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM; CORRECTED DATA: INADVERTENTLY DID NOT INCLUDE THAT THE LEAD REPLACEMENT WAS DUE TO A LEAD DISCONTINUITY ON FOLLOW-UP REPORT #1.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED ON THE IMPLANT CARD THAT THE REASON FOR LEAD REPLACEMENT WAS A ¿LEAD DISCONTINUITY¿. IT WAS REPORTED THAT THE HOSPITAL DISCARDS THE EXPLANTS AND THEREFORE CANNOT BE RETURNED FOR PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WENT TO THE ER ON (B)(6) 2014 DUE TO PAINFUL ERRATIC STIMULATION. THE ER PHYSICIAN AND NEUROLOGIST STATED THAT THE PATIENT¿S GENERATOR MAY BE AT END OF SERVICE. THE PATIENT HAD NOT FELT STIMULATION FOR THE PAST EIGHT MONTHS. BEFORE GOING TO THE ER, THE PATIENT WAS ON A SWING AND WAS HANGING BY HER LEFT ARM. THE PATIENT BEGAN EXPERIENCING PAINFUL STIMULATION AT 45 SECOND INTERVALS. THE PATIENT WAS ALSO EXPERIENCING TIGHTENING IN HER CHEST AND REPORTED THAT HER MAGNET WAS NOT WORKING. THE PATIENT HAD TO PRESS THE MAGNET EXTREMELY HARD AGAINST HER GENERATOR TO DISABLE HER DEVICE. TAPING THE MAGNET OVER THE GENERATOR WAS INEFFECTIVE IN DISABLING THE DEVICE. THE PATIENT WAS UNCERTAIN IF HER GENERATOR HAD MIGRATED. THE PATIENT WAS SEEN BY HER NEUROLOGIST ON (B)(6) 2014. THE NEUROLOGIST DECREASED THE PATIENT¿S DEVICE SETTINGS DURING THE OFFICE VISIT. THE NEUROLOGIST NOTED THAT THE PATIENT¿S VOICE ALTERATION HAD SIGNIFICANTLY INCREASED WITH STIMULATION. THE PATIENT FELT THAT STIMULATION WAS TRAVELING UP HER EAR AND AROUND HER TEMPLE. THE PHYSICIAN STATED THAT THE GENERATOR POCKET MAY HAVE EXPANDED AND THE GENERATOR MAY HAVE MIGRATED CAUSING THE MAGNET TO ACTIVATE MAGNET MODE STIMULATION INSTEAD OF DISABLING THE DEVICE. THE PATIENT¿S DEVICE WAS TESTED DURING THE OFFICE VISIT AND DIAGNOSTIC RESULTS SHOWED LEAD IMPEDANCE WITHIN NORMAL LIMITS. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014 BUT CONTINUED TO HAVE PAINFUL STIMULATION AFTER SURGERY. THE REPLACEMENT DEVICE HAD BEEN PROGRAMMED ON TO THE PATIENT¿S PREVIOUS DEVICE SETTINGS. A RADIOLOGY REPORT WAS RECEIVED BUT DID NOT OBSERVE ANY ISSUES WITH THE GENERATOR AND LEAD. THE PATIENT WAS REFERRED FOR LEAD REPLACEMENT SURGERY. LEAD REPLACEMENT SURGERY HAS NOT OCCURRED TO DATE. REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY SHOWED NORMAL DIAGNOSTIC RESULTS THROUGH (B)(6) 2012. A BATTERY LIFE CALCULATION USING THE AVAILABLE PROGRAMMING HISTORY SHOWED APPROXIMATELY 1.77 YEARS UNTIL ERI = YES. THE EXPLANTING FACILITY WILL NOT RETURN EXPLANTED DEVICES TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, NO ANALYSIS CAN BE PERFORMED.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT WAS STILL HAVING SYMPTOMS AFTER GENERATOR SETTINGS CHANGES. IT WAS NOTED THAT THE PATIENT NEEDS REPLACEMENT OF THE LEAD TO SEE IF THAT WILL HELP WITH HER SYMPTOMS AND ALLOW HER TO RECEIVE FULL VNS THERAPY. IT WAS NOTED THAT NO OTHER MAJOR CHANGES HAVE OCCURRED IN THE PATIENT'S MEDICAL HISTORY. AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT LEAD REPLACEMENT ON (B)(6) 2014. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318396 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200799

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention