BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 3902479 · Received June 30, 2014

    Report

    Report Number
    1644487-2014-01628
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 4, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT OR DATE OF BIRTH, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THIS INFORMATION WAS UNKNOWN. IT IS NOW KNOWN. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA. SEX, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THIS INFORMATION WAS UNKNOWN. IT IS NOW KNOWN. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA. BRAND NAME, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THIS INFORMATION WAS UNKNOWN. IT IS NOW KNOWN. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA. MODEL #, SERIAL #, LOT #, EXPIRATION DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THIS INFORMATION WAS UNKNOWN. IT IS NOW KNOWN. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA. IMPLANT DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THIS INFORMATION WAS UNKNOWN. IT IS NOW KNOWN. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA. MANUFACTURE DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THIS INFORMATION WAS UNKNOWN. IT IS NOW KNOWN. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: INADVERTENTLY SUBMITTED FOLLOW-UP REPORT #3 AS FOLLOW-UP REPORT #4.

    Description of Event or Problem · 1

    ON (B)(4) 2014, PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. 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. MAGNET ACTIVATIONS PERFORMED DURING OUTPUT MONITORING (AT A DISTANCE OF ONE-INCH, SPACER BLOCK, FROM THE GENERATOR), DEMONSTRATE THE APPROPRIATE MAGNET OUTPUT FOR THE PROGRAMMED SETTINGS. DIAGNOSTIC VALUES INDICATED THAT THE OUTPUT CURRENT REPORTED LOW (2.50MA) WITH THE DEVICE PROGRAMMED TO 2.75MA (3.00MA MAGNET). HOWEVER, THE MEASURED OUTPUT SIGNAL AMPLITUDE (BOTH PRIOR TO (11.12V (MAGNET 12.05V)) AND AFTER THE MONITORING TEST (11.12V (12.13V MAGNET)) DEMONSTRATES THAT THE GENERATOR IS ABLE TO DELIVER THE PROGRAMMED 2.75MA AND 3.00MA (WITH A 4K OHM LOAD CALCULATED OUTPUT 11.00V (12.00V MAGNET) +/- 10%) DESPITE THE WARNING MESSAGE OF A LOW OUTPUT CONDITION. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE BATTERY, 2.775 VOLTS AS MEASURED DURING COMPLETION OF THE FINAL ELECTRICAL TEST, SHOWS AN IFI=YES CONDITION. A BATTERY LIFE CALCULATION RESULTED IN 1.6 YEARS REMAINING BEFORE THE NEAR-END-OF-SERVICE (NEOS) FLAG WOULD BE SET TO A NEOS=YES CONDITION. PRODUCT ANALYSIS CONFIRMED LOW OUTPUT CURRENT MESSAGE DURING DIAGNOSTIC TESTING IN THE PA LAB WHICH IS A FUNCTION OF MONITORING TEST PERFORMED IN LAB, NOT OBSERVED IN THE FIELD; OTHERWISE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE WAS NOT WORKING. THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES AND WAS NOT ABLE TO FEEL MAGNET MODE STIMULATION. THE NEUROLOGIST WAS UNSURE WHETHER THE PATIENT¿S DEVICE WAS AT END OF SERVICE. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2014 AND SYSTEM DIAGNOSTIC RESULTS SHOWED NORMAL DEVICE FUNCTION AT THE TIME. THERE WERE NO CHANGES IN MEDICATION OR EXTERNAL FACTORS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE INCREASE IN SEIZURES, BUT IT WAS NOTED THAT THE INCREASE WAS BELOW PRE-VNS BASELINE LEVELS. THE PATIENT¿S DEVICE WAS EFFECTIVE IN REDUCING THE PATIENT¿S SEIZURES. THE PATIENT WAS REFERRED FOR SURGERY BUT NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2014 IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2014. THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS ON (B)(6) 2014. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380797 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS, INC. 104 200926

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR