BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3191451 · Received June 26, 2013

    Report

    Report Number
    1644487-2013-01934
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    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.

    Description of Event or Problem · 1

    THE LEAD ANALYSIS WAS COMPLETED ON (B)(4) 2013. NOTE THAT A PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE ABRADED OPENING AND SLICE MARKS FOUND ON THE OUTER SILICONE TUBING, MOST LIKELY PROVIDED THE LEAKAGE PATH FOR WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS FOUND INSIDE THE OUTER SILICONE TUBING. FOR THE OBSERVED INNER TUBING FLUID REMNANTS, THERE WAS NO OBVIOUS PATH FOR FLUID INGRESS OTHER THAN THE CUT ENDS THAT WERE MADE DURING THE EXPLANTED PROCESS. THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED. THE GENERATOR ANALYSIS WAS COMPLETED ON(B)(4) 2013. 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. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE (DCDC 7). THE PATIENT RECENTLY MOVED AND THIS WAS THE PHYSICIAN FIRST TIME SEEING THIS PATIENT. THE PATIENT REPORTED HE WAS LAST SEEN (B)(6) 2012 AND DIAGNOSTICS WERE WITHIN NORMAL LIMITS AT THAT TIME. PATIENT REPORTS HAVING AN INCREASE IN SEIZURES SINCE MOVING BUT THEY WERE BELOW BASELINE AND IT UNKNOWN IF THEY ARE RELATED TO THE HIGH IMPEDANCE OR VNS. THE GENERATOR WAS DISABLED AND THE PATIENT HAD X-RAYS TAKEN. BASED ON THE X-RAY RECEIVED THERE DID APPEAR TO BE A LEAD DISCONTINUITY IN THE NECK REGION WHICH MAY BE THE CAUSE OF THE HIGH IMPEDANCE. AS THE ENTIRE LEAD COULD NOT BE ASSESSED, CONTINUITY IN THAT PORTION OF THE LEAD CANNOT BE CONFIRMED. PATIENT DENIES ANY FALLS OR TRAUMA TO AREA BUT SAYS HE SOMETIMES DOES FALL WITH HIS SEIZURES. FOLLOW-UP INDICATED THAT IT WAS UNKNOWN OF THERE WERE ANY PROGRAMMING, MEDICATION OR OTHER CHANGES THAT PRECEDED THE EVENT BUT THERE DID NOT APPEAR TO BE ANY BASED ON THE PATIENT¿S RECORDS. THE OFFICE DOES NOT HAVE ANY PAST RECORDS FOR THE PATIENT AND IT IS UNKNOWN HOW HARD THEY WILL PUSH TO GET THESE RECORDS. THE PATIENT HAS BEEN REFERRED OR SURGERY BUT IT HAS NOT OCCURRED TO DATE. NO ADDITIONAL INFORMATION IS KNOWN BY THE OFFICE. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A GENERATOR AND LEAD REPLACEMENT. THE GENERATOR AND LEAD WERE RETURN TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291461 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1732

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other