BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3588892 · Received January 23, 2014

    Report

    Report Number
    1644487-2014-00288
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETROSPECTIVE SUMMARY REPORT EXEMPTION NUMBER (B)(4): 2,756 TOTAL EVENTS ARE BEING SUMMARIZED WITHIN THIS REPORT FOR PROGRAMMING ANOMALIES. CYBERONICS MADE A COMMITMENT TO FDA AS A SYSTEMIC ACTION ASSOCIATED WITH A 2012 FDA INSPECTION (FEI NUMBER (B)(4)) TO RETROSPECTIVELY REVIEW ALL EXISTING DATA IN AN INTERNAL PROGRAMMING HISTORY DATABASE (PHD), WHICH HOUSES DEVICE PROGRAMMING AND DIAGNOSTIC DATA FOR PATIENTS, TO IDENTIFY AND CONFIRM MDR REPORTABLE EVENTS THAT HAD NEVER BEEN PREVIOUSLY IDENTIFIED OR REPORTED TO CYBERONICS BY CUSTOMERS. THESE ITEMS WERE IDENTIFIED THROUGH THAT RETROSPECTIVE REVIEW.

    Description of Event or Problem · 1

    A RETROSPECTIVE REVIEW OF PROGRAMMING AND DIAGNOSTIC DATA WAS PERFORMED THAT IDENTIFIED 2,952 PROGRAMMING ANOMALY EVENTS. 2,954 TOTAL EVENTS WERE INITIALLY IDENTIFIED AND REPORTED AS PART OF A RETROSPECTIVE SUMMARY REPORTING REQUEST (RSR E2013044), BUT 1 OF THE EVENTS WAS LATER CONFIRMED INVALID, WITH ANOTHER HAVING BEEN PREVIOUSLY IDENTIFIED AND REPORTED TO THE FDA AS AN INDIVIDUAL REPORT (MEDWATCH #1644487-2013-01093). 2,756 OF THESE EVENTS ARE CAPTURED IN THE ATTACHED SPREADSHEET FOR PRODUCT CODE LYJ. THE REMAINING 196 EVENTS FOR ANOTHER PRODUCT CODE (MUZ) ARE CAPTURED IN MEDWATCH #1644487-2014-00289. THESE EVENTS REPRESENT INSTANCES WHERE A FAULTED SYSTEMS DIAGNOSTIC TEST RESULTED IN THE PATIENT LEAVING AN OFFICE VISIT AT UNINTENDED SETTINGS. THESE EVENTS ARE SPECIFIC TO PATIENTS WITH GENERATOR MODELS 100, 101, 102, OR 102R. NO SERIOUS INJURIES HAVE BEEN REPORTED ASSOCIATED WITH THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53531 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1