BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2555282 · Received May 1, 2012

    Report

    Report Number
    1644487-2012-01116
    Event Type
    Injury
    Date Received
    May 1, 2012
    Date of Event
    June 29, 2011
    Report Date
    April 12, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY DID NOT INCLUDE THAT ANOTHER GENERATOR DIAGNOSTIC TEST WAS PERFORMED FOLLOWING THE FAULTED SYSTEMS AND GENERATOR TEST ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT OR PRODUCT PROBLEM, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THE TYPE OF REPORTABLE EVENT INCORRECTLY. THE FAULTED GENERATOR DIAGNOSTIC TEST RESULTED IN THE PATIENT NOT RECEIVING THERAPY, AS THE OUTPUT CURRENT WAS INADVERTENTLY CHANGED TO 0.0MA. AS SUCH, THE EVENT IS AN ADVERSE EVENT. TYPE OF REPORTABLE EVENT, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THE TYPE OF REPORTABLE EVENT INCORRECTLY.

    Description of Event or Problem · 1

    A PHYSICIAN'S OFFICE REPORTED THAT DURING A ROUTINE CLINIC VISIT ON (B)(6) 2012, THE PATIENT REPORTED THAT SHE DID NOT FEEL ANY STIMULATION. UPON INTERROGATION OF THE PATIENT'S DEVICE, THE PHYSICIAN FOUND THAT THE DEVICE WAS SET AT 0MA WITH 60 MINUTES OFF TIME. IT WAS REPORTED THAT THE PATIENT WAS LAST SEEN IN (B)(6) 2011, AT WHICH TIME THE PHYSICIAN DID PERFORM A SYSTEM DIAGNOSTIC TEST AND EVERYTHING WAS REPORTEDLY FINE. THE PATIENT IS ONLY TREATED BY THE REPORTING PHYSICIAN FOR HER VNS. THE PHYSICIAN'S PROGRAMMING/DIAGNOSTIC HISTORY WAS COPIED ONTO A FLASHCARD AND RECEIVED BY THE MANUFACTURER. A REVIEW OF THE PROGRAMMING/DIAGNOSTIC HISTORY REVEALED THAT A GENERATOR DIAGNOSTIC TEST FAULTED AND PROGRAMMED THE OUTPUT CURRENT OFF. HOWEVER THE PHYSICIAN'S REPORT INDICATED THAT THE OFF TIME WAS 60 SECONDS UPON INITIAL INTERROGATION ON (B)(6) 2012, INDICATING THAT A FAULTED SYSTEMS TEST LIKELY CHANGED THE PATIENT'S SETTINGS TO UNINTENDED PARAMETERS ON THE PREVIOUS VISIT. THE SETTINGS WERE REPROGRAMMED ON (B)(6) 2012. HOWEVER BASED ON THE PROGRAMMING HISTORY, THE PATIENT'S SETTING CHANGE WERE CHANGED DUE TO THE GENERATOR DIAGNOSTIC TEST. A BATTERY LIFE CALCULATION WAS PERFORMED WITH THE HISTORY IN THE IN-HOUSE DATABASE, AND THE RESULTS WERE POSITIVE WITH APPROXIMATELY 3.09 YEARS UNTIL ERI=YES. THEREFORE, THE GENERATOR IS LIKELY NOT NEARING END OF SERVICE, SO THE PATIENT NOT PERCEIVING STIMULATION WAS RELATED TO THE OUTPUT CURRENT BEING UNINTENTIONALLY SET AT 0MA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR