BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2882949 · Received December 21, 2012

    Report

    Report Number
    1644487-2012-03437
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    September 1, 2012
    Report Date
    November 28, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT HAD PROPHYLACTIC GENERATOR REPLACEMENT SURGERY PERFORMED ON (B)(6) 2013. THE SEIZURES HAVE IMPROVED SINCE THE SURGERY. ATTEMPTS FOR ADDITIONAL INFORMATION AND RETURN OF THE EXPLANTED VNS GENERATOR ARE IN PROGRESS.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS OF THE GENERATOR WAS COMPLETED. PROPER FUNCTIONALITY OF THE PULSE GENERATOR IN ITS ABILITY TO PROVIDE APPROPRIATE PROGRAMMED OUTPUT CURRENTS WAS VERIFIED. IN ADDITION, THE SEPTUM WAS NOT CORED, THUS ELIMINATING THE POSSIBILITY OF A POTENTIAL UNINTENDED ELECTRICAL CURRENT PATH THROUGH BODY FLUIDS. IN THE PA 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. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE ELECTIVE-REPLACEMENT-INDICATOR (ERI) WAS OBSERVED PRIOR TO DECONTAMINATION, BUT WAS NOT DUPLICATED IN THE PA LAB. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. THE PATIENT IS CURRENTLY DOING VERY WELL WITH HIS SEIZURE CONTROL AND HIS SEIZURES HAVE IMPROVED SINCE REPLACEMENT. THE PAINFUL STIMULATION HAS ALSO RESOLVED, BUT THE PATIENT IS NOT YET BACK TO HIS ORIGINAL VNS SETTINGS AS HE IS STILL BEING TITRATED. AS THE SEIZURES ARE STABLE, SETTINGS WILL LIKELY STAY WHERE THEY ARE FOR NOW. THE EVENTS OF CONTINUOUS STIMULATION, PAINFUL STIMULATION, AND INCREASED SEIZURES BEGAN AFTER THE PATIENT WAS IN A MOTORCYCLE ACCIDENT IN (B)(6) 2012 AND THIS WAS THE EVENT THAT PRECIPITATED THE PATIENT'S ADVERSE EVENTS. DIAGNOSTICS ARE CURRENTLY OK. THE SEIZURES WERE JUST INCREASED IN GENERAL, AND THE TYPES WERE NOT SPECIFIED, BUT THE SEIZURES HAVE IMPROVED SINCE REPLACEMENT. THE CAUSE OF THE EVENTS ARE FELT TO BE LIKELY DUE TO THE ACCIDENT THE PATIENT HAD.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PATIENT WAS HAVING PROBLEMS SINCE A MOTORCYCLE ACCIDENT IN (B)(6) 2012. THE PATIENT WAS IN THE OFFICE ON (B)(6) 2012 STATING THAT HE WAS FEELING LIKE HE WAS HAVING CONTINUOUS STIMULATION AFTER MAGNET SWIPES. THE PHYSICIAN DISABLED THE GENERATOR FOR A WHILE THEN TURNED THE GENERATOR BACK ON DURING AN OFFICE VISIT ON (B)(6) 2012. PATIENT IS NOW SAYING HE HAS PAINFUL STIMULATION IN HIS NECK ANY TIME THE VNS IS TITRATED UP OR HE USES HIS MAGNET. THE PATIENT INDICATED THAT THE PAIN TYPICALLY GOES AWAY AFTER A WHILE. THE PATIENT'S CURRENT SETTINGS WERE PROVIDED, HOWEVER DIAGNOSTICS WERE NOT AVAILABLE. THE PHYSICIAN REPORTED THAT PATIENT IS ALSO HAVING AN INCREASE IN SEIZURES ABOVE HIS PRE-VNS BASELINE SINCE THE GENERATOR WAS TURNED BACK ON. THERE WERE SOME MEDICATION CHANGES DURING THAT TIME, BUT HE DOES NOT KNOW WHAT THE INCREASE IN SEIZURES IS ATTRIBUTED TO. ATTEMPTS FOR ADDITIONAL INFORMATION, INCLUDING DIAGNOSTIC RESULTS HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR HAS BEEN RETURNED AND IS PENDING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 016932

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR