BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3112173 · Received May 14, 2013

    Report

    Report Number
    1644487-2013-01362
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    END OF SERVICE MESSAGE SEEN UPON INTERROGATION OF THE PULSE GENERATOR.

    Description of Event or Problem · 1

    THE GENERATOR WAS RETURNED ON (B)(4) 2013 AND IS PENDING PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT EOS=YES WAS SEEN DURING AN INITIAL IMPLANT SURGERY. DIAGNOSTICS OUTSIDE OF THE POCKET WERE WITHIN NORMAL LIMITS; HOWEVER, DIAGNOSTICS ONCE THE GENERATOR AS PLACED INSIDE THE POCKET INDICATED EOS=YES. DIAGNOSTICS WERE PERFORMED SEVERAL TIMES WITH THE SAME RESULTS. THE SURGEON DENIED USE OF ELECTROCAUTERY. THE GENERATOR HAS NOT BEEN RETURNED TO DATE.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS APPROVED ON (B)(4) 2013. THE PREMATURE END OF LIFE WAS DUPLICATED IN THE PA LAB. AN END-OF-SERVICE WARNING MESSAGE WAS VERIFIED IN THE PA LAB AND FOUND TO BE ASSOCIATED WITH THE OUTPUT BEING DISABLED BY THE PULSE GENERATOR. 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 THE DEVICE WAS OPERATING PROPERLY. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DATA SHOWS THAT 1.434% OF THE BATTERY HAD BEEN CONSUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213093 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202360

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR