BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3201854 · Received July 2, 2013

    Report

    Report Number
    1644487-2013-02015
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 11, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE ISSUE WAS THAT THE GENERATOR HAD BEEN UNABLE TO BE INTERROGATED. THE PHYSICIAN REPORTED THAT IT WAS MOST LIKELY THAT THE BATTERY WAS AT END OF LIFE BUT THE PATIENT¿S MOTHER HAD THE IMPRESSION THAT THE SYSTEM WAS STILL WORKING.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE GENERATOR REPLACEMENT ON (B)(6) 2013 DUE TO ¿NO CONTACT WITH STIMULATOR BUT COULD BE WORKING AGAIN¿. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN WERE UNSUCCESSFUL. THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS ON (B)(6) 2013. PRODUCT ANALYSIS FOUND AN END-OF-SERVICE (EOS) CONDITION WAS FOUND IN THE PA LABORATORY AND DETERMINED TO BE THE RESULT OF NORMAL EXPECTED BATTERY DEPLETION, BASED ON THE BATTERY LIFE ANALYSIS AND ELECTRICAL TEST RESULTS. THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. 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
    302497 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200863

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR