BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 4915695 · Received July 15, 2015

    Report

    Report Number
    1644487-2015-05199
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 15, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE GENERATOR DATA WAS REVIEWED. THE DATA REVEALED THAT A 25% BATTERY INDICATOR WAS OBSERVED WHEN THE % OF BATTERY CAPACITY USED WAS AT APPROXIMATELY 8%. ONCE THE % OF BATTERY CAPACITY USED WAS >10%, THE BATTERY INDICATOR "REBOUNDED" AND WAS OBSERVED WAS FULL. A PREVIOUS INVESTIGATION WAS PERFORMED ON PREVIOUS REPORTS OF BATTERY STATUS INDICATOR OF 25% RECEIVED SOONER THAN EXPECTED AND LATER RETURNED TO 100% WITHOUT ANY SIGNIFICANT PROGRAMMING CHANGES. THE INVESTIGATION DETERMINED THAT THE BEHAVIOR WAS LIKELY RELATED TO AN INCREASED DURATION OF THE HIGH BATTERY IMPEDANCE EXPERIENCED BY CFX BATTERIES DURING THE BEGINNING OF LLFE OR AN INTERNAL SHORT THAT MANAGED TO "BURN" ITSELF OUT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2015. THE EXPLANTED GENERATOR HAS BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT'S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2015 AND THE DEVICE SHOWED AN IFI CONDITION. CLINIC NOTES WERE RECEIVED INDICATING THAT THE PHYSICIAN BELIEVED THE BATTERY HAD DEPLETED PREMATURELY SINCE IT WAS IMPLANTED ON (B)(6) 2015. ADDITIONAL PROGRAMMING HISTORY WAS RECEIVED WHICH SHOWED LEAD IMPEDANCE WITHIN NORMAL LIMITS AND AN IFI CONDITION ON (B)(6) 2015. A BATTERY LIFE CALCULATION USING THE AVAILABLE PROGRAMMING HISTORY SHOWED APPROXIMATELY 1.7 YEARS REMAINING. REVIEW OF THE DECODER DATA SHOWED BATTERY VOLTAGE WAS 2.784V (IFI - YES) WITH 30.085% OF THE BATTERY CONSUMED ON (B)(6) 2015. THE PATIENT WAS REFERRED FOR SURGERY BUT NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S GENERATOR BATTERY STATUS WAS FLUCTUATING ON THE HANDHELD. IT WAS REPORTED THAT THE BATTERY WAS CHANGING FROM FULL TO ABOUT HALF FULL, TO LESS THAN HALF AND THEN BACK UP TO FULL WITHIN THE SAME APPOINTMENT. IT WAS REPORTED THAT DEVICE DIAGNOSTICS WERE WITHIN NORMAL LIMITS. IT WAS REPORTED THAT THERE HAD BEEN NO ELECTRICAL SHOCKS, LIGHTENING STRIKES OR OTHER SURGERIES USING ELECTROCAUTERY THAT MAY HAVE CONTRIBUTED TO THE DEVICE BATTERY FLUCTUATING. THE PATIENT WAS SEEN AGAIN AND THE BATTERY INDICATOR AGAIN SHOWED LESS THAN 25%. THE PATIENT WAS SEEN AGAIN AT A LATER DATE AT WHICH TIME THE BATTERY INDICATOR WAS FULL. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    MONITORING OF THE DEVICE OUTPUT SIGNAL SHOWED 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 BATTERY MEASURED 2.950 VOLTS AND AN IFI=NO CONDITION. THE DATA IN THE DIAGACCUM-CONSUMED MEMORY LOCATIONS REVEALED THAT 40.400% 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
    461163 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS, INC. 104 4237

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR