BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2963540 · Received February 15, 2013

    Report

    Report Number
    1644487-2013-00413
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    October 1, 2012
    Report Date
    January 17, 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

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY. PREVIOUSLY SUBMITTED MDR INADVERTENTLY OMITTED INFORMATION. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION.

    Description of Event or Problem · 1

    REVIEW OF PROGRAMMING HISTORY SHOWS NO DATA AFTER (B)(6) 2011. BASED ON THE AVAILABLE SETTINGS, THE NOMINAL ESTIMATED BATTERY WOULD BE LESS THAN SEVEN YEARS. THE STIMULATION NOT PERCEIVED EVENTS WERE REPORTED IN ADDITION TO A FAILURE TO PROGRAM ON THE GENERATOR; IT IS STILL UNKNOWN IF THIS IS RELATED TO END OF SERVICE. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A PATIENT COULD NO LONGER FEEL VNS STIMULATION SINCE VISITING A FACTORY IN (B)(6) 2012 WHERE MAGNETIC FIELDS WERE ENCOUNTERED. THE PATIENT ALSO NO LONGER FELT VNS MAGNET STIMULATION. NO CAUSAL OR CONTRIBUTORY VNS PROGRAMMING CHANGES OR OTHER CHANGES PRECEDED THE STIMULATION NOT PERCEIVED EVENT. THE PATIENT HAD NO TRAUMA AND DOES NOT MANIPULATE THE VNS. NO INTERVENTIONS ARE CURRENTLY PLANNED. THE PATIENT HAS NOT FOLLOWED UP WITH THE PHYSICIAN IN TWO YEARS. IT IS POSSIBLE THE GENERATOR IS AT END OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68106 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 012704

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR