BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3241453 · Received July 22, 2013

    Report

    Report Number
    1644487-2013-02213
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    BOTH THE INITIALLY IMPLANTED MODEL 102 GENERATOR AND REPLACEMENT MODEL 105 GENERATOR WERE RETURNED ON (B)(4) 2013. MODEL 105 PRODUCT ANALYSIS RESULTS: AN END-OF-SERVICE WARNING MESSAGE WAS VERIFIED IN THE PRODUCT ANALYSIS LAB AND FOUND TO BE ASSOCIATED WITH THE OUTPUT BEING DISABLED BY THE PULSE GENERATOR. BURN MARKS WERE ALSO OBSERVED ON THE BACK SIDE OF PULSE GENERATOR CAN, WHICH INDICATED THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL. ONCE THE OUTPUT WAS RE-ENABLED, RESULTS OF ELECTRICAL TEST RESULTS DEMONSTRATED THAT THE PULSE GENERATOR WAS OPERATING WITHIN SPECIFICATION. RESULTS OF DIAGNOSTIC TESTING INDICATED THAT THE BATTERY STATUS INDICATED OK. THE BATTERY VOLTAGE VALUE STORED WITHIN THE GENERATOR (3.017 VOLTS REPORTED DURING FET) SUGGESTS THE DEVICE IS NOT AN NEOS CONDITION. WITH THE EXCEPTION OF THE BURN MARKS AND DISABLED OUTPUT CONDITION THERE WERE NO OTHER ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. MODEL 103 PRODUCT ANALYSIS RESULTS: PRODUCT ANALYSIS FOUND THAT THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS SET. THE BATTERY WAS PARTIALLY DEPLETED AND DETERMINED TO BE THE RESULT OF NORMAL EXPECTED BATTERY CONSUMPTION BASED ON THE BATTERY LIFE ANALYSIS AND ELECTRICAL TEST RESULTS. THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED DURING A GENERATOR REPLACEMENT THAT NEW GENERATOR INDICATED THAT IT WAS NEAR END OF SERVICE. THE NEW GENERATOR WAS CONNECTED TO THE LEAD AND THERE WERE NO ANY UNUSUAL FLAGS OR WARNINGS. THE SURGEON PREFORMED SYSTEMS DIAGNOSTICS, INSIDE AND OUTSIDE THE POCKET AND THE ¿NEOS¿ WARNING WAS RECEIVED. THE SURGEON INDICATE THAT THERE WAS NO ELECTROSURGERY IN THE STERILE FIELD WHILE THE GENERATOR WAS PRESENT OR DURING THE PROCEDURE AND DID NOT DO ANY ADJUSTMENTS ON THE LEAD PIN/SETSCREW TO POSSIBLY CAUSE ELECTRO-STATIC DISCHARGE. THERE WAS NO BACK-UP PRODUCT AVAILABLE AND THE SURGEON DECIDED TO LEAVE THE GENERATOR IMPLANTED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR TO DISTRIBUTION. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340340 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202502

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR