XLTEK PROTEKTOR
Received Apr 4, 2018 · Event occurred Mar 30, 2018
Report 7395216 · MDR key 7395216
Device
Generic name
Stimulator, Electrical, Evoked Response
Product problems
- False Positive Result
- Failure to Sense
Patient
63 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IN THE MIDDLE OF THE OR CASE WE ABRUPTLY LOST ALL SIGNALS FOR SOMATOSENSORY EVOKED POTENTIALS (SSEPS)-UPPERS AND LOWERS- FOR A POSTERIOR LUMBAR FUSION SURGERY. WE COULD VISIBLY SEE THE LEFT HAND MOVING TO THE STIM WITHOUT ANY CLEAR CORTICAL RESPONSE ON THE COMPUTER, BUT THE RIGHT HAND HAD NO VISIBLE TWITCH AND NO RESPONSE IN THE COMPUTER. BOTH LEGS REMAINED MOVING WITH STIM WHILE THE RESPONSES WERE MARKEDLY DECREASED. WE FINALLY REBOOTED AND ALL SIGNALS RETURNED TO BASELINE. CLEARLY, THIS WAS A TECHNICAL ISSUE WITH THE EQUIPMENT. THIS DELAYED SURGERY FOR THE PATIENT AND UNNECESSARILY GAVE A FALSE POSITIVE TO THE SURGEON. THIS IS NOT THE FIRST TIME THESE ERRORS HAVE OCCURRED, THOUGH IT IS THE MOST SEVERE HAVING LOST ALL SIGNALS WITH A MIXED CLINICAL PRESENTATION. MANUFACTURER RESPONSE FOR EEG, IOM, XLTEK PROTEKTOR (PER SITE REPORTER): WAITING FOR A RESPONSE.