BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2770804 · Received October 3, 2012

    Report

    Report Number
    1644487-2012-02502
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    July 9, 2012
    Report Date
    September 7, 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

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A GENERATOR M103 SN (B)(4) ON (B)(6) 2010, WAS HAVING HER DEVICE CHECKED AT A ROUTINE OFFICE APPOINTMENT ON (B)(6) 2012 AND INTERROGATION OF HER DEVICE REVEALED IFI = NO; HOWEVER, WHEN THE PATIENT WAS IN THE OFFICE ON (B)(6) 2012, THE IFI WAS SET TO YES. THE PHYSICIAN WAS CONCERNED ABOUT THE BATTERY STATUS CHANGING FROM IFI = YES TO IFI = NO, WHEN THERE HAD BEEN NO CHANGES TO THE DEVICE SETTINGS AND IMPEDANCE VALUES WERE SIMILAR. THE PATIENT WAS SAID TO BE PROGRAMMED TO 3.25/30/500/30/1.8. THE PROGRAMMING HISTORY FROM THE PHYSICIANS HANDHELD WAS RECEIVED FOR REVIEW. REVIEW OF THE GENERATOR SOURCE CODE VIA THE DECODER SPREADSHEET REVEALED THE FOLLOWING: ON (B)(6 )2012 - 3.25/30/500/30/3; IMPEDANCE = 2336OHMS; % BATT. USED= 27.853%; VBAT= 2.846V (SHOWING BATTERY GAUGE WITH 25% BATTERY REMAINING ON HHD) ON (B)(6) 2012 - INIT. INTERR 3.25/30/500/30/3; IMPEDANCE = 2215 OHMS; % BATT. USED= 34.255%; VBAT= 2.737V (SHOWING YELLOW BATTERY GAUGE IFI = YES) ON (B)(6) 2012 - SDX AT 3.25/30/500/30/1.8; IMPEDANCE = 2215 OHMS; % BATT. USED= 34.256%; VBAT= 2.762V (SHOWING YELLOW BATTERY GAUGE IFI = YES) ON (B)(6) 2012 - INIT. INTERR 3.25/30/500/30/1.8; IMPEDANCE = 2268 OHMS; % BATT. USED= 40.336%; VBAT= 2.849V (SHOWING BATTERY GAUGE WITH 25% BATTERY REMAINING ON HHD) ON (B)(6) 2012 - INIT. INTERR 3.25/30/500/30/1.8; IMPEDANCE = 2336 OHMS; % BATT. USED= 46.413%; VBAT= 2.848V (SHOWING BATTERY GAUGE WITH 25% BATTERY REMAINING ON HHD) OF NOTE, THE BATTERY VOLTAGE DECREASED AFTER THE (B)(6) 2012 OFFICE VISIT UNTIL (B)(6) 2012. AT THE MORE RECENT FOLLOW UP VISITS IN (B)(6) 2012, THE BATTERY VOLTAGE INCREASED BACK UP ABOVE THE IFI THRESHOLD. ALSO OF NOTE IS THE % BATTERY CAPACITY CONSUMED WOULD TYPICALLY BE IN THE RANGE OF 82%-92% WHEN THE BATTERY VOLTAGE IS BELOW 2.8V. HOWEVER, THE % CONSUMED WAS ONLY 34.255% AT A BATTERY VOLTAGE OF 2.727V. THE TRIM VALUES RELEVANT TO BATTERY VOLTAGE MEASUREMENT APPEARED TO BE WITHIN NORMAL RANGES AT THE TIME OF MANUFACTURE, WHICH WAS IN (B)(6) 2010 (I.E. DIAGVBATB = 99, DIAGVBATM = 137, DIAGONCONSUMEDM = 2983). A REVIEW OF THE DEVICE HISTORY REVIEW WAS PERFORMED FOR THE M103 SN (B)(4) WHICH REVEALED THAT THE DEVICE PASSED ALL QUALITY CHECKS AND MANUFACTURING INSPECTIONS, ALL ELECTRICAL TESTS PASSED, AND THERE WERE NO UNRESOLVED NONCONFORMANCE REPORTS PRIOR TO SHIPMENT. NO FURTHER INFORMATION HAS BEEN ATTAINED AT THIS TIME. .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT HAVE ANY SURGERIES, MEDICAL PROCEDURES, TRAVELS, OR PARTICIPATE IN ANY ACTIVITIES OUT OF NORMAL ACTIVITIES AFTER (B)(6) 2012. IN ADDITION, THE PATIENT WAS NOT SEEN BY ANY OTHER PHYSICIAN OR SITE WHERE ANOTHER HHD MAY HAVE BEEN USED TO INTERROGATE/PROGRAM THE PATIENT'S DEVICE. THEREFORE IT APPEARS THAT ALL OF THE DEVICES' PROGRAMMING HISTORY IS AVAILABLE, AND WAS PREVIOUSLY REVIEWED. IF AT A LATER DATE THE PATIENT HAS SURGERY AND HAS THEIR GENERATOR REPLACED ATTEMPTS WILL BE MADE FOR PRODUCT RETURN FOR ANALYSIS.

    Description of Event or Problem · 1

    THE PATIENT WENT TO SURGERY TO HAVE THEIR GENERATOR REPLACED. PRIOR TO SURGERY IT WAS INTERROGATED AND IT SHOWED PROPER DEVICE FUNCTION WITH IFI: YES. THEIR EXPLANTED GENERATOR WAS SENT TO PATHOLOGY. IT HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 201567

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR