BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2895487 · Received January 3, 2013

    Report

    Report Number
    1644487-2013-00027
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS PERFORMED ON THE GENERATOR AND FOUND NO DEVICE FAILURE. VISUAL EXAMINATION SHOWED TOOL MARKS THE PULSE GENERATOR CASE AND HEADER. THESE TOOL MARKS ARE MOST LIKELY ASSOCIATED WITH MANIPULATION OF THE DEVICE DURING THE EXPLANT PROCEDURE AS THE OBSERVED MARKINGS ARE CONSISTENT WITH DEVICES TYPICALLY USED IN A SURGICAL PROCEDURE (FORCEPS, ETC.). THE SEPTUM NOT CORED. NO OTHER SURFACE ABNORMALITIES (SUCH AS SHARP EDGES, HEADER DELAMINATION, OPEN POCKETS, DECOMPOSITION, CORROSION OR VOIDS) WERE NOTED ON THIS DEVICE. THE SETSCREW SHOWED SLIGHT MECHANICAL WEAR AROUND THE SOCKET AND SEPTUM DEBRIS IN THE SETSCREW SOCKET. NO BURRED OR STRIPPED THREADS WERE OBSERVED ON THE RETURNED SETSCREW OR ON THE NEGATIVE CONNECTOR BLOCK OF THE RETURNED PULSE GENERATOR. THIS OBSERVATION/FINDING IS NOT CONSIDERED A DEVICE FAILURE, BUT INSTEAD THE RESULT OF EXTENSIVE MANIPULATION OF THE PRODUCT. IN ADDITION, TOOL MARKS WERE OBSERVED ON THE NEGATIVE FEED-THRU WIRE. THIS OBSERVATION/FINDING IS NOT CONSIDERED A DEVICE FAILURE, BUT INSTEAD THE RESULT OF EXTENSIVE MANIPULATION OF THE PRODUCT DURING THE MANUFACTURING PROCESS AND WOULD NOT CONTRIBUTE TO 'REMOVAL DIFFICULTIES' OR 'DEVICE FAILURE' ALLEGATIONS. THE PULSE GENERATOR WAS SUBJECTED TO X-RAY MACHINE FOR AN INTERNAL VISUAL ASSESSMENT. REVIEW OF THE PULSE GENERATOR X-RAYS REVEALED NO VISUAL ANOMALIES. NO OBSTRUCTIONS WERE OBSERVED IN THE HEADER LEAD CAVITY OR CONNECTOR BLOCKS. IN ADDITION, THE IN-LINE CAVITY GO GAUGE TEST, DESIGNED TO VERIFY PROPER LEAD CAVITY DIMENSIONS IN THE HEADER AREA, PASSED. A BENCH LEAD INSERTED COMPLETELY PAST THE NEGATIVE CONNECTOR BLOCK AND WAS SET AND RELEASED WITH THE RETURNED SETSCREW (LAB CONDITIONS). THE BENCH TEST LEAD REMOVED FROM THE PULSE GENERATOR HEADER WITH NO DIFFICULTIES (LAB CONDITIONS). VARIOUS ELECTRICAL LOADS WERE ATTACHED TO THE GENERATOR AND RESULTS OF DIAGNOSTIC TESTS DEMONSTRATE THAT ACCURATE RESISTANCE MEASUREMENTS WERE OBTAINED IN ALL INSTANCES. IN THE 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 DATA IN THE "DIAGACCUMCONSUMED" MEMORY LOCATIONS REVEALED THAT 1.143% OF THE BATTERY HAD BEEN CONSUMED. OTHER THAN THE VISUAL OBSERVATION, THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. PRODUCT ANALYSIS OF THE LEAD FOUND NO OBVIOUS ANOMALIES THAT COULD PREVENT PROPER INSERTION OR REMOVAL OF THE LEAD CONNECTOR FROM THE PULSE GENERATOR HEADER. AVERAGE VALUES OF THE CONNECTOR PIN, CONNECTOR RING AND O-RINGS (SMALL AND LARGE) DIAMETER MEASUREMENTS ARE WITHIN TOLERANCE. THE IDENTIFIED SETSCREW INDENTATIONS ON THE CONNECTOR PIN AND THE TORN CONNECTOR WERE MOST LIKELY CAUSED BY THE FORCE EXERTED BY THE USER DURING MANIPULATION OF THE LEAD AS DESCRIBED IN THE EVENT DESCRIPTION. EXTENSIVE DEEP INDENTATIONS (NOT RELATED TO THE SETSCREW) WERE OBSERVED NEAR THE TIP OF THE CONNECTOR PIN. WHEN RECEIVED INTO PA, THE TORN CONNECTOR PORTION, CONTAINING THE LEAD PIN AND RING HAD ALREADY BEEN REMOVED FROM THE GENERATOR. THEREFORE, IT CANNOT BE DETERMINED WHEN THE PIN DAMAGE WAS SUSTAINED, EVEN THOUGH THE REMOVAL PROCESS APPEARS TO BE THE MOST LIKELY CAUSE. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL CONDITIONS OBSERVED AFTER MANIPULATION OF THE LEAD, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD ASSEMBLY. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DURING THE PATIENT'S NEW IMPLANT SURGERY, THE SURGEON PLACED THE LEADS ON THE VAGUS NERVE AND THEN PLACED THE LEAD PIN IN THE CONNECTOR BLOCK OF THE GENERATOR WITHOUT TIGHTENING DOWN THE SCREW. DIAGNOSTIC TESTS WERE RUN WHICH INDICATED HIGH LEAD IMPEDANCE. THE SURGEON ATTEMPTED TO DISCONNECT THE LEAD FROM THE GENERATOR SO THAT HE COULD RE-INSERT IT AGAIN FOR THE IMPEDANCE; HOWEVER, HE WAS UNABLE TO PULL IT OUT. HE UNSCREWED AND RESCREWED THE CONNECTOR BLOCK SEVERAL TIMES EVEN THOUGH HE HAD NOT TIGHTENED IT INITIALLY, BUT THE LEAD WAS STILL UNABLE TO BE REMOVED. IN A FINAL ATTEMPT TO PULL THE LEAD OUT OF THE GENERATOR, THE SILICON COVERING OVER THE LEAD PIN BECAME DETACHED AND REMAINED IN THE GENERATOR. THE GENERATOR AND LEAD WERE REMOVED FROM THE PATIENT AND A NURSE CAME IN TO SEE IF HE COULD REMOVE THE LEAD WITH A SCREWDRIVER. AFTER THREE ATTEMPTS, A NEW GENERATOR AND LEAD WERE USED FOR THE PATIENT'S IMPLANT. BOTH THE GENERATOR AND LEAD WERE RETURNED ON (B)(4) 2012 AND ARE PENDING PRODUCT ANALYSIS. A DEVICE HISTORY REVIEW FOR THE LEAD AND GENERATOR CONFIRMED THAT BOTH DEVICES MET ALL FINAL TESTING SPECIFICATIONS PRIOR TO DISTRIBUTION. NO PROGRAMMING HISTORY WAS AVAILABLE FOR THE DEVICE AS IT HAD NOT BEEN FULLY IMPLANTED; HOWEVER, THE PHYSICIAN REPORTED THAT HIGH IMPEDANCE WAS SEEN DURING IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3382

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR