OMNI™ II Programmer System (with OMNI Smart Software)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810003380012), received between Jul 24, 2020 and Jul 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Data Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2020Data Problem; Data Problem

  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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323349 ↗