BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART SYSTEM

    MDR report key: 10323349 · Received July 24, 2020

    Report

    Report Number
    3007805252-2020-00001
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    June 10, 2020
    Report Date
    July 23, 2020
    Manufacturer
    IMPULSE DYNAMICS (USA) INC.
    Product Code
    QFV
    UDI-DI
    00810003380012
    PMA / PMN Number
    P180036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISCREPANCY BETWEEN THE PROGRAMMER SCREEN DISPLAY AND THE HARD COPY PRINT-OUT OF THE ZEBRA PRINTER WAS FIRST OBSERVED AT THE UNIVERSITY OF MANNHEIM IN GERMANY. THE PROGRAMMER WAS NOT RETURNED TO MANUFACTURER. REPLICATES OF THE EXACT SAME PROGRAMMER AND ZEBRA PRINTER WERE TAKEN FROM STOCK INVENTORY IN THE US AND GERMANY AND THE DISCREPANCY WAS REPRODUCIBLE. THE CONTRACT MANUFACTURER FOR THE PROGRAMMER WAS CONTACTED AND INITIAL EVALUATION IS THAT THERE IS A SOFTWARE BUG THAT REQUIRES SOME TEXT LABELS TO BE CORRECTED IN THE EXISTING SOFTWARE CODE. THE FIX IS BEING DEVELOPED AND WILL BE IMPLEMENTED IN THE FIELD. H11 - CORRECTED DATA ((B)(6) 2020) THE DEVICE MALFUNCTION REPORTED WAS A SOFTWARE BUG WHERE THE VALUES FOR %THERAPY WERE INCORRECT FOR THE HARD COPY PRINTER OUTPUT BUT CORRECT ON THE DISPLAY SCREEN OF THE PROGRAMMER. THERE WAS NO SERIOUS INJURY, HARM OR DEATH TO THE PATIENT. AFTER REVIEWING THE RISKS, IT IS UNLIKELY THE RECURRENCE OF THIS DISCREPANCY WOULD LEAD TO PATIENT HARM BECAUSE MOST SITES DO NOT USE THE ZEBRA PRINTER INVOLVED AND THE VALUES TRANSPOSED ARE RELATIVELY CLOSE IN CLINICAL APPLICATION. IMPULSE DYNAMICS IS REPORTING THIS EVENT OUT OF CAUTION. A FSCA WAS CONDUCTED WHEREBY A RESOLUTION TO THE SOFTWARE BUG WAS LOADED ONTO AFFECTED PROGRAMMERS AS AN UPGRADE TO THE UNITS. THE FSCA HAS BEEN MOSTLY COMPLETED WITH A VERY SMALL NUMBER OF UNITS THAT HAVE NOT BEEN UPGRADED YET DUE TO LIMITED ACCESS POSED BY THE COVID-19 CRISIS. THESE WILL BE COMPLETED AS SOON AS ACCESS IS GRANTED. THE UPGRADES HAVE BEEN SUCCESSFUL AND THE UPGRADE INTRODUCES NO NEW RISKS. THERE IS A LOW CHANCE THAT THE SOFTWARE BUG WILL RECUR WITH UPGRADED PROGRAMMERS. THIS MATTER IS DEEMED TO BE CLOSED FROM THE MANUFACTURER'S PERSPECTIVE.

    Description of Event or Problem · 0

    OMNI II PROGRAMMER WITH OMNI SMART APPLICATION SOFTWARE SCREEN DISPLAY DOES NOT MATCH HARD COPY PAPER PRINT-OUT FROM ASSOCIATED ZEBRA PRINTER. THE VALUES FOR %THERAPY TOTAL AND %THERAPY 24 HOURS ARE TRANSPOSED. THE VALUES ON PROGRAMMER DISPLAY SCREEN ARE CORRECT. THE PHYSICIAN USERS RARELY USE THE ZEBRA PRINTER HARD COPY BUT THE POSSIBILITY EXISTS THAT IN SOME RARE CASE THE PHYSICIAN MAY DECIDE TO USE IT OR PLACE IT IN THE PATIENT MEDICAL RECORD. BECAUSE THE PHYSICIAN WILL ADJUST THERAPY ON THE BASIS OF THE PROGRAMMER SCREEN DISPLAY, THE RISK OF HARM TO THE PATIENT IS REMOTE. PATIENT PROBLEM CODE : 2199 (NO CONSEQUENCES OR IMPACT TO PATIENT).

    Additional Manufacturer Narrative · 1

    THE DISCREPANCY BETWEEN THE PROGRAMMER SCREEN DISPLAY AND THE HARD COPY PRINT-OUT OF THE ZEBRA PRINTER WAS FIRST OBSERVED AT (B)(6). THE PROGRAMMER WAS NOT RETURNED TO MANUFACTURER. REPLICATES OF THE EXACT SAME PROGRAMMER AND ZEBRA PRINTER WERE TAKEN FROM STOCK INVENTORY IN THE US AND (B)(6) AND THE DISCREPANCY WAS REPRODUCIBLE. THE CONTRACT MANUFACTURER FOR THE PROGRAMMER WAS CONTACTED AND INITIAL EVALUATION IS THAT THERE IS A SOFTWARE BUG THAT REQUIRES SOME TEXT LABELS TO BE CORRECTED IN THE EXISTING SOFTWARE CODE. THE FIX IS BEING DEVELOPED AND WILL BE IMPLEMENTED IN THE FIELD.

    Description of Event or Problem · 1

    THE OMNI II PROGRAMMER WITH OMNI SMART APPLICATION SOFTWARE IS USED TO PROGRAM THE OPTIMIZER SMART IPG. OMNI II PROGRAMMER WITH OMNI SMART APPLICATION SOFTWARE SCREEN DISPLAY DOES NOT MATCH HARD COPY PAPER PRINT-OUT FROM ASSOCIATED ZEBRA PRINTER. THE VALUES FOR %THERAPY TOTAL AND %THERAPY 24 HOURS ARE TRANSPOSED. THE VALUES ON PROGRAMMER DISPLAY SCREEN ARE CORRECT. THE PHYSICIAN USERS RARELY USE THE ZEBRA PRINTER HARD COPY BUT THE POSSIBILITY EXISTS THAT IN SOME RARE CASE THE PHYSICIAN MAY DECIDE TO USE IT OR PLACE IT IN THE PATIENT MEDICAL RECORD. BECAUSE THE PHYSICIAN WILL ADJUST THERAPY ON THE BASIS OF THE PROGRAMMER SCREEN DISPLAY, THE RISK OF HARM TO THE PATIENT IS REMOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783215 OPTIMIZER SMART SYSTEM IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS (USA) INC. 10-A604-3-US 00810003380012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other N/A.