BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2972240 · Received February 21, 2013

    Report

    Report Number
    1644487-2013-00470
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 1, 2012
    Report Date
    January 22, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE 'LEAD ISSUE' WAS HIGH IMPEDANCE. A HIGH IMPEDANCE WARNING MESSAGE WAS RECEIVED ON INTERROGATION. THERE WERE NO X-RAYS THAT WERE NOTED TO HAVE BEEN TAKEN. THE ORIGINAL PLAN WAS TO REPLACE THE PATIENT LEAD BUT WHEN THE SURGEON WAS PERFORMING THERE WAS A LOT OF SCARING AROUND THE CAROTID AND JUGULAR AND IT WAS HARD TO DISSECT TO THE VAGAL NERVE. SINCE THIS WAS THE PATIENT'S SECOND LEAD THERE WAS NOT ENOUGH EXPOSED NERVE TO IMPLANT ANOTHER. THE FAMILY WAS AWARE THAT IT MAY BE TOO RISKY TO RE-IMPLANT. THE SCARING RELATIONSHIP TO VNS WAS UNKNOWN. THE PATIENT WAS HAVING AN INCREASE IN SEIZURES DUE TO THE HIGH IMPEDANCE AND THERE WERE NO ADDITIONAL CONTRIBUTING FACTORS NOTED. IT WAS UNKNOWN IF THE INCREASE IN SEIZURES WERE ABOVE PRE-VNS BASELINE SINCE THE PATIENT HAS HAD VNS FOR A LONG TIME AND IT WAS UNKNOWN WHAT THE PATIENT'S SEIZURE LEVEL WAS PRIOR TO VNS. VNS AND ONE MEDICATION WERE THE ONLY THINGS THAT HAD EVEN HELPED WITH HIS SEIZURES. THERE WAS NO KNOWN MANIPULATION OR TRAUMA. SHE ALSO COMMENT THAT HAD THERE BEEN A FALL OR ANYTHING THAT WOULD HAD AFFECTED THE LEAD THE NURSES AT THE HOME WOULD HAVE BEEN AWARE OF IT AND WOULD HAVE REPORTED IT TO THEM. PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR AND LEAD. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED ON THE SURFACE OF THE COILS, A SHORT DISTANCE FROM THE CUT COIL END. THE EXACT REASON FOR THIS CONDITION IS UNKNOWN. NOTE THAT SINCE A PORTION OF THE LEAD (INCLUDING THE ELECTRODE ARRAY) WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATION, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. THE GENERATOR 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 BATTERY MEASURED AT 3.007 VOLTS SHOWS A NON-IFI CONDITION. THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT 35.856% OF THE BATTERY HAD BEEN CONSUMED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS GOING TO HAVE SURGERY DUE TO A "BAD LEAD". IT WAS ALSO REPORTED THAT THE PATIENT'S SEIZURES HAD BEEN WORSE OVER THE PAST YEAR WHICH MAY HAVE BEEN RELATED TO THE "BAD LEAD". THE PATIENT HAD HIS GENERATOR AND LEAD EXPLANTED REPORTED BY THE HOSPITAL TO BE DUE TO THE PATIENT NEEDING TO HAVE MORE MRI AND DESIRE TO HAVE THE SYSTEM EXPLANTED. THE GENERATOR AND LEAD WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76625 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-30 200476

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR