BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3223928 · Received July 12, 2013

    Report

    Report Number
    1644487-2013-02094
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    August 1, 2011
    Report Date
    June 17, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2013. THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS ON (B)(4) 2013. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED FOR THE PATIENT¿S REFERRAL FOR GENERATOR REPLACEMENT. THE PATIENT HAD THE INITIAL NEUROLOGY VISIT WITH THE PHYSICIAN ON (B)(6) 2011 FOR A SECOND OPINION BECAUSE THE MOTHER WAS ADVISED THAT THE ¿VNS DOES NOT WORK¿ FOR THE PATIENT¿S INTRACTABLE SEIZURES. THE MOTHER WAS ADVISED THAT THE PATIENT¿S SEIZURES WERE LONGER AND THAT THEY HAD CHANGED; SHE WAS NOW HAVING MYOCLONIC/TONIC SPASMS ONE TO THREE TIMES PER DAY LASTING FIVE TO TEN MINUTES THAT OCCUR MOSTLY AFTER AWAKENING. NO CHANGES TO VNS PARAMETERS WERE MADE ON THIS DATE. THE PATIENT WAS DISCONTINUED ON ONE MEDICATION AND WAS SLOWLY WEANED OFF ANOTHER, WHILE BEGINNING A NEW MEDICATION SLOWLY. LATER ON (B)(6) 2012, THE MOTHER NOTED NO CHANGES IN THE PATIENT¿S SEIZURES SINCE (B)(6) 2011. THE PATIENT HAS TWO TYPES OF SEIZURES. FOR ABOUT A YEAR AND A HALF AT THIS POINT, THE PATIENT HAD ¿DROP¿ SEIZURES WHICH OCCURRED ABOUT TWICE A DAY AND LAST ABOUT 10 SECONDS EACH. THE SECOND TYPE OF SEIZURE CONSISTS OF SPASMS AND OCCUR IN CLUSTERS OF 5-10 MINUTES WHICH OCCUR DAILY SINCE 6 MONTHS OF AGE. THE PATIENT WAS WEANED OFF THE NEW MEDICATION AND STARTED ON ANOTHER. AGAIN, NO VNS CHANGES WERE MADE. ON (B)(6) 2013 VISIT, THE MOTHER NOTED THE NEW MEDIATION WAS WORKING WELL FOR THE PATIENT¿S ¿SPASMS¿ AND ¿DROP SEIZURES¿ DRAMATICALLY. THE DROP SEIZURES WERE OCCURRING ABOUT THREE TIMES PER DAY BUT NOW ARE OCCURRING ABOUT TWICE A DAY. VNS INTERROGATION SHOWED BATTERY LIFE WAS ¿LOW,¿ AND NO CHANGES WERE MADE. THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT. ATTEMPTS FOR ADDITIONAL INFORMATION ON THE RELATIONSHIP OF THE CHANGE IN SEIZURE PATTERN TO VNS HAVE BEEN UNSUCCESSFUL THUS FAR. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PHYSICIAN RESPONDED TO THE MANUFACTURER'S FAX REQUEST FOR INFORMATION. IT WAS STATED THAT THERE WAS NO CHANGE IN SEIZURE FREQUENCY REPORTED AT THE (B)(6) 2013 VISIT. IN REGARDS TO CAUSAL OR CONTRIBUTORY PROGRAMMING OR MEDICATION CHANGES WHICH MAY HAVE PRECEDED THE ONSET OF THE CHANGE IN SEIZURE PATTERN, THE PHYSICIAN STATED THAT THE BATTERY METER WAS IN THE RED. PRIOR TO VNS, THE PATIENT EXPERIENCED THE SAME MYOCLONIC AND TONIC SPASMS. THIS SEIZURE PATTERN HAS NOT CHANGED. PER THE PHYSICIAN, THE PATIENT HAS BENEFITTED FROM VNS THERAPY. NO DIAGNOSTIC HISTORY WAS AVAILABLE; HOWEVER, IT WAS NOTED THAT NEOS WAS YES. PRODUCT ANALYSIS OF THE RETURNED GENERATOR WAS PERFORMED. VISUAL EXAMINATION, PERFORMED AT THE PA TEST BENCH SHOWED TOOL MARKS LIKELY ASSOCIATED WITH MANIPULATION OF THE DEVICE DURING THE EXPLANT PROCEDURE. BURN MARKS WERE OBSERVED ON THE PULSE GENERATOR CASE INDICATING THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL. IN ADDITION, RESIDUE WAS OBSERVED ON THE PULSE GENERATOR FEED-THRU ASSEMBLY AND IS KNOWN TO BE RELATED TO THE MANUFACTURING PROCESS OF THE COMPONENT. THE SEPTUM WAS CORED, BUT NO BODILY FLUID REMNANTS WERE OBSERVED IN THE HEADER SEPTUM CAVITY. NO OTHER SURFACE ABNORMALITIES WERE NOTED ON THIS DEVICE. AN INTERROGATION AND SYSTEM DIAGNOSTICS TEST WAS PERFORMED. THE FOLLOWING RESULTS WERE NOTED (LOAD RESISTOR/REPORTED DIAGNOSTICS RESULTS, ALL VALUES IN OHMS AND BATTERY STATUS): 4000/3927 WITH IFI YES. RESULTING STATUS CHECKS FOR; COMMUNICATION WERE OK, LEAD IMPEDANCE AND CURRENT DELIVERED WERE NORMAL FOR ALL DIAGNOSTIC TESTS PERFORMED. THE DIAGNOSTIC VBAT CALCULATION RESULTS WERE 2.690 VOLTS. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. PROPER FUNCTIONALITY OF THE PULSE GENERATOR IN ITS ABILITY TO PROVIDE APPROPRIATE PROGRAMMED OUTPUT CURRENTS CAN BE VERIFIED. IN THE PRODUCT ANALYSIS LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS SHOWING NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT. 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 90.544% OF THE BATTERY HAD BEEN CONSUMED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322560 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201216

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention