NEUROSIGN
Report
- Report Number
- 8021774-2021-00010
- Event Type
- Malfunction
- Date Received
- July 28, 2021
- Report Date
- March 29, 2022
- Manufacturer
- THE MAGSTIM COMPANY LIMITED
- Product Code
- ETN
- PMA / PMN Number
- K923056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRELIMINARY INVESTIGATION / DEVICE EVALUATION: TWO FAULTS WERE REPORTED ON THIS DEVICE, THE FIRST BEING INTERFERENCE EXPERIENCE WHEN USING A DRILL ALONG SIDE AND THE SECOND BEING THE ERRATIC/INACCURATE ELECTRIC STIMULATION. GIVEN IT IS A KNOWN FACT THAT THE USE OF A DEVICE INCORPORATING A MOTOR MAY INTRODUCE INTERFERENCE ON INTRAOPERATIVE NERVE MONITORS, FOR THE PURPOSE OF THIS REPORT ONLY THE ERRATIC/INACCURATE ELECTRIC STIMULATION SHALL BE CONSIDERED. THE DEVICE WAS RETURNED TO MAGSTIM ON 28/05/2021, HOWEVER NO CONTACT WAS MADE WITH MAGSTIM UNTIL 24/06/2021, SO NO INVESTIGATION WAS BEGAN UNTIL A RMA WAS RAISED. MAGSTIM THEN REACHED OUT TO AUDIOSALUD FOR MORE INFORMATION FOR WHAT OCCURRED. AUDIOSALUD REPRESENTATIVE ANDRES STATED THAT THERE WERE NO HEALTH IMPACTS TO PATIENTS BUT THE DEVICES STIMULATION BEING PRODUCED WAS ERRATIC AND HAD BECOME NOT TRUSTED BY THE SURGEONS BECAUSE OF THIS. ONCE MAGSTIM WERE MADE AWARE THAT THE DEVICE WAS INVESTIGATED AND THE ENGINEER DISCOVERED THAT THE LEMO CONNECTOR ON N100 WAS UPSIDE DOWN, THERE WERE INCORRECT SCREWS FITTED IN TOP COVER AND ODD CABLE TIE INSIDE UNIT WHICH IS EVIDENCE THAT N100 HAS BEEN OPENED. THE STIMULATOR OUTPUT PULSE WAS UNSTABLE. IT FAILS THE TEST 4.9 OF 9883-01 TM, STIM PULSE IS ONLY 2-3V WHEN SET TO 5.0M. THE FAULT WAS ABLE TO BE REPLICATED SHOWING AN UNSTABLE STIMULATOR PULSE. IT WAS ESTABLISHED THAT THE CAUSE OF THE UNSTABLE STIMULATOR PULSE WAS DUE TO A FAULTY COMPONENT ON THE 2528-01 PCB STIMULATOR, THE POTENTIOMETER, P/N475048. ROOT CAUSE: THE FAULT WAS DISCOVERED TO BE A FAULTY COMPONENT ON 2528-01 PCB STIMULATOR POTENTIOMETER, P/N475048, THIS HAS BEEN REPLACED. A REPORT FCSAA 2022-02 WAS CREATED TO INVESTIGATED IF ANY FURTHER ACTIONS WERE REQUIRED, IT DETERMINED: "GIVEN DEVICES ARE LIKELY BEING USED BEYOND THEIR DEFINED LIFETIME, IT IS NOT POSSIBLE TO IDENTIFY THE EXACT NUMBER OF DEVICES CURRENTLY IN USE ON THE MARKET SINCE THE APPLICATION OF THE CE MARK, ONLY A RECORD OF SALES. 51 DEVICES REMAIN ON THE MARKET WITHIN THE DEFINED 5 YEAR LIFETIME. (B)(4). CONSENSUS OF IN-FIELD RISK REMAINING LOW TO BOTH PATIENT AND USER, WITH THE CLINICAL BENEFITS STILL OUTWEIGHING THE RISK OF NON-USE. PROPOSED ACTION TO CONTACT CUSTOMERS OF DEVICES AND REMIND OF DISCONTINUATION OF CE MARKING DUE TO MARKETING ISSUES AND TO ENSURE CONTINUED SUPPORT, RECOMMEND CUSTOMERS PERFORM ANNUAL SURVEILLANCE CHECK WITH LEGAL MANUFACTURER OF DEVICE TO CHECK PERFORMANCE. THIS ACTION WILL BE DRIVE BY SALES AND THE PRODUCT MANAGER AS PART OF THEIR CUSTOMER FEEDBACK/MONITORING/SERVICE ACTIVITIES. THIS MAY TAKE THE FORM OF A PHONE CALL, IN-PERSON FACILITY VISIT, OR VIA EMAIL NOTIFICATION. ISSUE WILL BE MONITORED TO MAINTAIN TRACK AND TREND ANALYSIS TO DETERMINE THE REQUIREMENT FOR FIELD SAFETY ACTIONS. WILL ALSO BE MONITORED IN QIG."
ON THE (B)(6) 2021 IT WAS REPORTED THAT THERE WERE PROBLEMS OF INTERFERENCE WITH THE DRILLING MACHINES (THE IMPEDANCES OR MV ACTIVITY RISES MORE THAN NORMAL MAKING MONITORING IMPOSSIBLE) AND DOCTORS COMMENT THAT THE ELECTRICAL STIMULATION IS ERRATIC AND INACCURATE. THERE WERE ALSO NO KNOWN HEALTH IMPACTS.
TWO FAULTS WERE REPORTED ON THIS DEVICE, THE FIRST BEING INTERFERENCE EXPERIENCE WHEN USING A DRILL ALONG SIDE AND THE SECOND BEING THE ERRATIC/INACCURATE ELECTRIC STIMULATION. DUE TO THE SENSITIVE NATURE OF INTRA-OPERATIVE NERVE MONITORS TO ACHIEVE THEIR INTENDED USE, IT IS A KNOWN FACT THAT THE USE OF A DEVICE INCORPORATING A MOTOR MAY INTRODUCE INTERFERENCE ON INTRA-OPERATIVE NERVE MONITORS. FOR THIS REASON, FOR THE PURPOSE OF THIS REPORT, ONLY THE ERRATIC/INACCURATE ELECTRIC STIMULATION SHALL BE CONSIDERED AS THIS SITUATION IS NOT ACCORDING TO THE SPECIFICATION OF THE PRODUCT. THE DEVICE WAS RETURNED TO MAGSTIM ON 28/05/2021, HOWEVER NO CONTACT WAS MADE WITH MAGSTIM UNTIL 24/06/2021, SO NO INVESTIGATION WAS BEGAN UNTIL A RMA WAS RAISED. MAGSTIM THEN REACHED OUT TO AUDIOSALUD FOR MORE INFORMATION FOR WHAT OCCURRED. AUDIOSALUD REPRESENTATIVE ANDRES STATED THAT THERE WERE NO HEALTH IMPACTS TO PATIENTS BUT THE DEVICES STIMULATION BEING PRODUCED WAS ERRATIC AND HAD BECOME NOT TRUSTED BY THE SURGEONS BECAUSE OF THIS. ONCE MAGSTIM WERE MADE AWARE THAT THE DEVICE HAD ALREADY BEEN RETURNED FOR REPAIR THE DEVICE WAS INSPECTED FOR ANY PROBLEMS. THE DEVICE WAS INVESTIGATED AND THE ENGINEER DISCOVERED THAT THE LEMO CONNECTOR ON N100 WAS UPSIDE DOWN, THERE WERE INCORRECT SCREWS FITTED IN TOP COVER AND ODD CABLE TIE INSIDE UNIT WHICH WHILST NOT DIRECTLY ATTRIBUTING TO THE FAILURE MODE REPORTED, SUGGESTS THAT N100 HAS BEEN OPENED BY AN UNAUTHORISED PERSON / CENTRE. WHEN ATTEMPTING TO REPLICATE / CONFIRM THE REPORTED FAULT, THE STIMULATOR OUTPUT PULSE WAS VERIFIED AS BEING UNSTABLE. WHEN SUBJECTING THE ACTUAL DEVICE TO ITS PRODUCTION TEST METHOD (9883-01 TM), THE DEVICE FAILED THE TEST AT SECTION 4.9, WHERE THE STIM PULSE WAS MEASURED AT 2-3V WHEN SET TO 5.0MA (REQUIREMENT 4.5V - 5.5V). THE CAUSE OF THE FAILURE WAS ATTRIBUTED TO BE A FAULTY POTENTIOMETER COMPONENT P/N475048 ON THE 2528-01 PCB STIMULATOR BOARD. THIS COMPONENT HAS SINCE BEEN REPLACED.
ON THE (B)(6) 2021 IT WAS REPORTED THAT THERE WERE PROBLEMS OF INTERFERENCE WITH THE DRILLING MACHINES (THE IMPEDANCES OR MV ACTIVITY RISES MORE THAN NORMAL MAKING MONITORING IMPOSSIBLE) AND DOCTORS COMMENT THAT THE ELECTRICAL STIMULATION IS ERRATIC AND INACCURATE. THERE WERE ALSO NO KNOWN HEALTH IMPACTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1139907 | NEUROSIGN | NEUROSIGN 100 | ETN | THE MAGSTIM COMPANY LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |