BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2090739 · Received April 26, 2011

    Report

    Report Number
    1644487-2011-00895
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    June 30, 2010
    Report Date
    March 31, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH. REVIEW OF MANUFACTURING RECORDS FOR THE GENERATOR REVEALED THAT ALL LINE ITEMS WERE SIGNED OFF PRIOR TO DISTRIBUTION AND ALL ELECTRICAL TESTS AND VISUAL INSPECTIONS WERE PASSED PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED BY A VNS TREATING PHYSICIAN THROUGH CLINIC NOTES RECEIVED BY CASE MANAGEMENT THAT THE VNS PATIENT WAS BEING REFERRED TO HAVE THEIR PULSE GENERATOR REPLACED DUE TO ERI= YES. THE PATIENT WAS EXPERIENCING A RECENT INCREASE IN SEIZURE FREQUENCY AND INTENSITY, BELIEVED BY THE PHYSICIAN TO BE RELATED TO THE DEAD BATTERY. THE PATIENT HAD SURGERY ON (B)(6) 2011 WHERE THE GENERATOR WAS REPLACED. DURING SURGERY THE SURGEON ACCIDENTALLY CUT THE LEAD, LEADING TO REPLACEMENT OF THE LEAD AS WELL. THE EXPLANTED PRODUCTS WERE RETURNED TO MANUFACTURER FOR ANALYSIS. ANALYSIS OF THE LEAD REVEALED NO ANOMALIES. ANALYSIS OF THE GENERATOR CONFIRMED THE ERI=YES CONDITION, AND WAS FOUND TO BE DUE TO NORMAL BATTERY DEPLETION BASED ON THE ELECTRICAL TEST RESULTS, AND THE BATTERY LIFE CALCULATION. THE GENERATOR WAS NOT AT COMPLETE EOS CONDITION (DEFINED AT 2.2V) AS THE MEASURED BATTERY VOLTAGE WAS 2.378V. DURING ANALYSIS, A MAGNET (CYBERONICS PAGER STYLE) WAS APPLIED TO THE PULSE GENERATOR, AT DISTANCE OF ONE INCH, BUT THE MAGNET CURRENT WOULD NOT ACTIVATE. HOWEVER, AT APPROXIMATELY 0.75 INCHES FROM THE PULSE GENERATOR THE OUTPUT CURRENT CEASED WHEN THE MAGNET WAS APPLIED TO THE PULSE GENERATOR AND THE MAGNET CURRENT ACTIVATED AFTER THE MAGNET WAS REMOVED FROM THE PULSE GENERATOR. THE PLASTIC HOUSING OVER THE REED SWITCH (S1) WAS SUBSTITUTED WITH AN EXTERNAL REED SWITCH. THE PULSE GENERATOR MODULE THEN PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE REED SWITCH FUNCTIONS DO NOT AFFECT THE SUPPLY CURRENT, SO THIS OBSERVED REED SWITCH CONDITION SHOULD HAVE NO ADVERSE EFFECT ON BATTERY LONGEVITY. THE FAILURE MECHANISM FOR THE REED SWITCH (S1) WAS NOT ASCERTAINED. ADDITIONALLY DURING ANALYSIS OF THE GENERATOR, A VISUAL ASSESSMENT ON THE FEED-THRU ASSEMBLY, PERFORMED AT THE PRODUCT ANALYSIS TEST BENCH, SHOWED POSSIBLE EXCESSIVE BENDS IN THE POSITIVE FEED-THRU WIRE. IN ADDITION, SEPARATION OF THE SILVER POLYIMIDE TO POSITIVE AND NEGATIVE FEED-THRU WIRE CONNECTIONS WAS OBSERVED. VERIFIED AT THE BENCH, WHEN EITHER OF THE FEED-THRU WIRES (OF THE FEED-THRU ASSEMBLY) WERE MANIPULATED, THE CAPACITANCE VALUE WAS VARIABLE AND PERIODICALLY MEASURED AN OPEN (ELECTRICALLY OPEN) OR 3.7NF (LIMITS ARE 2.7NF TO 5.4NF). THE MOST PROBABLE ROOT CAUSE FOR THE BACKUP CAPACITOR TESTS WAS IDENTIFIED TO BE AN OPEN CAPACITOR, WHICH MANIPULATION OF THE FEED-THRU WIRES MAY HAVE BEEN A CONTRIBUTING FACTOR. THE VNS PROGRAMMING HISTORY DATABASE WAS REVIEWED FOR THE PATIENT'S GENERATOR TO REVIEW MAGNET ACTIVATION HISTORY. THERE IS DIAGNOSTIC HISTORY AVAILABLE FROM THE DATE OF IMPLANT ON (B)(6) 2006 UP THRU (B)(6) 2010, WHERE ALL DIAGNOSTICS WERE NOTED TO BE WITHIN NORMAL LIMITS. THERE WAS NO INDICATION IN REVIEW OF THE HISTORY OF ANY MAGNET MODE DIAGNOSTICS TEST RESULTS PERFORMED ON THIS DEVICE. REVIEW OF THE MAGNET ACTIVATION HISTORY REVEALED THAT THERE WERE MAGNET ACTIVATIONS RECORDED ON (B)(6) 2008, INDICATING THAT THE REED SWITCH WAS FUNCTIONAL FOR A PERIOD OF TIME AFTER THE DEVICE WAS IMPLANTED. THE MOST RECENT HISTORY WAS UPLOADED INTO THE IN HOUSE DATABASE IN NOV 2010, AND THE LAST MAGNET ACTIVATION RECORDED WAS FROM (B)(6) 2008. THE LAST INTERROGATION SETTING AVAILABLE IN HOUSE IS DATED (B)(6) 2008, WHERE THE MAGNET MODE OUTPUT CURRENT WAS PROGRAMMED TO 3.25MA. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN TO NO AVAIL THUS FAR. IT IS UNKNOWN IF THE PATIENT WAS NOT USING THE MAGNET TO INITIATE MAGNET MODE STIMULATION, OR IF THE REED SWITCH FAILED AT SOME POINT IN TIME WHILE IMPLANTED (AFTER (B)(6) 2008). REVIEW OF THE M102, SN (B)(4) MANUFACTURING RECORDS WAS PERFORMED AND ALL LINE ITEMS WERE SIGNED OFF PRIOR TO DISTRIBUTION. ALL ELECTRICAL TESTS AND VISUAL INSPECTIONS WERE PASSED PRIOR TO SHIPMENT. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 015168

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention