BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3980999 · Received August 5, 2014

    Report

    Report Number
    1644487-2014-01938
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    May 1, 2014
    Report Date
    July 10, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE VNS PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014. THE EXPLANTED GENERATOR HAS NOT BEEN RETURNED TO DATE. A BATTERY LIFE CALCULATION USING THE AVAILABLE PROGRAMMING HISTORY SHOWED APPROXIMATELY 3.2 YEARS UNTIL ERI = YES ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014 BECAUSE THE PATIENT WAS UNABLE TO PERCEIVE STIMULATION AND BELIEVED HIS DEVICE WAS NOT WORKING. THE PATIENT¿S DEVICE WAS DISABLED WHILE THE PATIENT WAS IN THE HOSPITAL. AT DISCHARGE, THE NEUROLOGIST PROGRAMMED THE PATIENT¿S DEVICE BACK ON TO ITS ORIGINAL SETTINGS; HOWEVER, THE PATIENT WAS UNABLE TO TOLERATE STIMULATION SO THE DEVICE SETTINGS WERE DECREASE. CLINIC NOTES WERE RECEIVED INDICATING THAT THE VNS PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014. SINCE THE PATIENT¿S LAST HOSPITALIZATION ON (B)(6) 2014, THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES AND HAD 20 SEIZURES IN THE PAST TWO WEEKS PRIOR TO HOSPITALIZATION. THE PATIENT¿S DEVICE SETTINGS WERE INCREASED UPON ADMISSION AND AGAIN ON (B)(6) 2014. THE PATIENT SUBSEQUENTLY COMPLAINED OF CHEST PRESSURE, COUGHING AND VOICE CHANGES, BUT THE SYMPTOMS RESOLVED AND THE PATIENT WAS ABLE TO TOLERATE THE NEW DEVICE SETTINGS. THE PATIENT¿S NEW SETTINGS WERE STILL LOWER THAN HIS BASELINE DEVICE SETTINGS. THE PATIENT STATED THAT HIS DEVICE WAS NOT WORKING PROPERLY; HOWEVER, THE NOTES INDICATE THAT THE PATIENT¿S VOICE CHANGES AND COUGHING SHOWED THAT THE PATIENT¿S DEVICE WAS PROVIDING STIMULATION. FURTHERMORE, THE PATIENT¿S DEVICE WAS TESTED AND SYSTEM DIAGNOSTICS SHOWED NORMAL DEVICE FUNCTION AT THE TIME. CONTINUOUS VIDEO-EEG MONITORING SHOWED THAT THE PATIENT WAS NOT IN STATUS. THE PATIENT¿S MEDICATIONS WERE ADJUSTED FOR BETTER SEIZURE CONTROL; HOWEVER, THE PATIENT SUBSEQUENTLY HAD A CLUSTER OF SEIZURES ON (B)(6) 2014 AFTER THE MEDICATION ADJUSTMENTS. THE PATIENT¿S MEDICATIONS WERE RE-ADJUSTED AND THE PATIENT DID NOT HAVE ANY MORE SEIZURES WHILE HOSPITALIZED. THE PATIENT WAS DISCHARGED ON (B)(6) 2014. THE PATIENT WAS REFERRED FOR SURGERY BUT NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE. FOLLOW-UP REVEALED THAT THE PATIENT¿S INCREASE IN SEIZURES BEGAN IN (B)(6) 2014. THE NEUROLOGIST ATTRIBUTES THE VOICE CHANGES TO STIMULATION AND STATED THAT THE INCREASE IN SEIZURES MAY HAVE BEEN RELATED TO THE PATIENT¿S MEDICATIONS. THE PATIENT HAS SINCE HAD BETTER SEIZURE CONTROL WITH MEDICATION ADJUSTMENTS BUT CONTINUES TO HAVE PAINFUL STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456864 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200969

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R