BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3242863 · Received July 23, 2013

    Report

    Report Number
    1644487-2013-02222
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: FOLLOW-UP REPORT #01 INADVERTENTLY LISTED THE WRONG RESULTS AND CONCLUSION CODES. THESE CODES SHOULD BE REMOVED. THE DEVICE FAILURE THAT OCCURRED WAS NOT RELATED TO THE INITIALLY REPORTED EVENT. THE FAILURE THAT OCCURRED WAS REPORTED IN MFR. REPORT # 1644487-2013-02761.

    Description of Event or Problem · 1

    THE GENERATOR WAS RETURNED DUE TO LOW BATTERY, EOS=STATUS UNKNOWN AND FAILURE TO PROGRAM. AN END-OF-SERVICE WAS DUPLICATED IN THE PA LAB, THE BATTERY IS DEPLETED, 0.059 VOLTS AS MEASURED WITH THE CAN REMOVED AND BATTERY STILL ATTACHED TO THE PCB. A POST BURN-IN ELECTRICAL TEST FAILED TEST RELATED TO REED SWITCH OPERATION. THE REED SWITCH FAILURE WAS DUE TO THE EXCESSIVE GAP BETWEEN THE PADDLES. NO PACKAGING ISSUES WERE NOTED ON THE RETURNED PRODUCT. ALL OTHER PARAMETERS WERE WITHIN SPECIFICATIONS WHICH INCLUDES CURRENT DRAIN. OTHER THAN NOTED CONDITIONS THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. THE ISSUE WITH THE REED SWITCH WAS REPORTED IN MFR #: 1644487-2013-02761.

    Description of Event or Problem · 1

    ANALYSIS OF THE PROGRAMMING HISTORY DECODER REVEALED THAT THE GENERATOR BATTERY VOLTAGE MEASURE 2.809V ON (B)(6) 2012 WHICH INDICATES THAT 25% OF THE BATTERY IS REMAINING. THE PERCENT BATTERY CONSUMED WAS ~75% WHICH IS IN LINE WITH THE MEASURED BATTERY VOLTAGE. REVIEW OF THE CALIBRATED VALUES ESTABLISHED DURING MANUFACTURING OF THE DEVICE IN THE FLASH MEMORY REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    THE BATTERY OF GENERATOR WAS SENT TO THE BATTERY VENDOR FOR ANALYSIS TO ASSESS THE ELECTRICAL PERFORMANCE OF THE BATTERY DUE TO THE LOW BATTERY VOLTAGE OBSERVED IN THE RETURNED DEVICE AND TO ENSURE THAT NO ANOMALIES WITH THE BATTERY EXISTED WHICH COULD HAVE CONTRIBUTED TO THE LOW BATTERY VOLTAGE. ANALYSIS ACTIVITIES PERFORMED BY THE VENDOR INCLUDED VISUAL INSPECTION OF THE AS RECEIVED BATTERY, REVIEW OF THE DEVICE HISTORY RECORDS, OPEN CELL MEASUREMENT AND BATTERY THICKNESS, X-RAY IMAGES, MICROCALORIMETRY, COMPLEX IMPEDANCE SPECTROSCOPY, AND DESTRUCTIVE ANALYSIS TO ASSESS THE INTEGRITY OF THE ELECTRODES AND SEPARATORS. THE RESULTING ANALYSIS FINDINGS REVEALED NO ANOMALIES WITH THE BATTERY. NOTE THAT ALTHOUGH THE VENDORS REPORT STATED IN THE CONCLUSIONS SECTION THAT THERE WERE NO DEFECTS IDENTIFIED DURING THEIR ANALYSIS THAT WOULD ACCOUNT FOR THE EARLY DEPLETION OF THE BATTERY, THERE WAS NO ALLEGATION THAT THE DEVICE PREMATURELY REACHED EOS. THE REASON FOR ANALYSIS OF THE BATTERY WAS TO EVALUATE THE DEVICE FOR ANY DEFECTS WHICH COULD HAVE CONTRIBUTED TO THE LOW BATTERY VOLTAGE. THE LOW BATTERY VOLTAGE APPEARS TO BE NORMAL, AND IT IS NOTED THAT THE LAST KNOWN DEVICE SETTINGS WERE RATHER HIGH (3.5MA AND A 36% DUTY CYCLE), AND GIVEN THAT THE DEVICE PASSED ALL BOARD LEVEL ELECTRICAL AND FUNCTIONAL TESTS DURING ANALYSIS THUS RULING OUT ANY COMPONENT ISSUES, THE HIGH DEVICE SETTINGS WAS LIKELY THE REASON THE RATHER LOW BATTERY VOLTAGE SEEN DURING ANALYSIS OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT WAS INITIALLY REFERRED FOR SURGERY PROPHYLACTICALLY, DUE TO THE IFI WARNING FLAG BEING SEEN. HOWEVER, THE DEVICE WAS UNABLE TO BE INTERROGATED DURING PRE-OP. IT IS UNKNOWN WHEN THE IFI FLAG WAS FIRST SEEN. IT IS ALSO UNKNOWN WHY THE DEVICE WAS UNABLE TO BE INTERROGATED, AS BOTH PROGRAMMING SYSTEMS USED TO INTERROGATE THE DEVICE WERE CONFIRMED TO BE WORKING. THE LAST KNOWN DIAGNOSTICS FROM THE PROGRAMMING HISTORY DATABASE IS FROM (B)(6) 2012 WITH THE RESULTS: COMMUNICATION = OK, OUTPUT STATUS = OK, IMPEDANCE VALUE = 2211 OHMS, ERI = OK. THE EXPLANTED GENERATOR WAS RETURNED ON (B)(4) 2013 AND IS PENDING PRODUCT ANALYSIS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342429 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201083

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR