| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NIM? EMG ELECTRODE | ELECTRODE, NEEDLE | MEDTRONIC XOMED INC. | GXZ | 8227411 | 8227411 | 0211402935 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-27 | 0 |
Patient 1
CONCOMITANT MEDICAL PRODUCTS. 8225101 ? PROBE, 5PK STD PRASS FLUSH TIP; LOT NUMBER - 0210923677; MANUFACTURE DATE ? MARCH 3, 2016; (B)(4); THE 510K - K934426. THE DEVICE HAS NOT BEEN RECEIVED. A PRODUCT ANALYSIS HAS NOT BEEN COMPLETED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Patient 1
IT WAS REPORTED THAT INTRAOPERATIVE, THE ELECTRODES AND PROBE COULD NOT DETECT NERVES PROPERLY. THE DOCTOR HAD REINSERTED THE ELECTRODES AND TRIED ANOTHER DEVICE. THE USER WAS UNABLE TO RESOLVE THE ISSUE. THEREFORE, THE DOCTOR COMPLETED THE SURGERY WITHOUT THE NIM SYSTEM. THERE WAS NO PATIENT INJURY.
Patient 1
(B)(4) (LOT NUMBER 0211402935): THE PRODUCT ANALYSIS INDICATES THAT ONE UN-SEALED SAMPLE WAS RECEIVED. VISUALLY, THERE WAS NO DAMAGE OR ANOMALIES IN THE CONSTRUCTION OF THE DEVICE THAT WOULD HAVE RESULTED IN THE REPORTED EVENT. THE PAIRED SUBDERMAL ELECTRODES SHALL EXHIBIT CONTINUITY FROM NEEDLE TIP TO CONNECTING PIN WITH A MEASUREMENT LESS THAN 2.0OHMS [AND SHALL EXHIBIT INFINITY BETWEEN NEEDLES AND CONNECTORS]. THE BLUE PAIRED MEASURED 1.7OHMS / 1.7OHMS, THE RED PAIRED MEASURED 1.6OHMS / 1.6OHMS, THE PURPLE PAIRED MEASURED 1.7OHMS / 1.7OHMS, AND THE ORANGE PAIRED MEASURED 1.7OHMS / 1.7OHMS. ALL ELECTRODES WERE INFINITE BETWEEN POLES AND NO OUT OF SPECIFICATION CONDITION WAS IDENTIFIED. THE RED/WHITE AND GREEN ELECTRODES END TO END OHMS RESISTANCE SHALL BE LESS THAN 2.5 OHMS. THE ACTUAL MEASUREMENTS FOR THE RED/WHITE WAS 0.8 OHMS. THE ACTUAL MEASUREMENTS FOR THE GREEN WAS 0.9 OHMS INDICATING AN IN-SPECIFICATION CONDITION. THIS IS A SUPPLIED MATERIAL ASSEMBLY WITH NO OUT OF SPECIFICATION CONDITION. (B)(4) (LOT NUMBER 0210923677): THE PRODUCT ANALYSIS INDICATES THAT ONE UNSEALED SAMPLE WAS RECEIVED. VISUALLY, THERE WAS NO DAMAGE OR ANOMALIES IN THE CONSTRUCTION OF THE DEVICE THAT WOULD HAVE RESULTED IN THE REPORTED EVENT. THE TIP FIT SECURELY IN THE HANDLE. THE PROBE WAS PLUGGED INTO A NIM SYSTEM USING 1.0 MA STIMULATING CURRENT AND 100UV THRESHOLD. WHEN STIMULATING, THE SYSTEM RETURNED 1.02 MA AND A WAVEFORM / TONE OVER 200UV. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING AND NO MALFUNCTION FOUND AS IT RELATES TO THE COMPLAINT.
Patient 1
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PROCEDURE PERFORMED WAS A MIDDLE EAR SURGERY. THE DEVICE(S) DELIVERED NON-NERVE SOUNDS THAT LET THE USER KNOW THE DEVICE WAS NOT WORKING PROPERLY. THE STIM WAS SET AT 2 AND 3. WHEN THE STIM WAS SET AT 2, THE RETURN VALUE WAS 1.99. WHEN THE STIM WAS SET AT 3, THE RETURN VALUE WAS 2.99. THE SYSTEM RECOGNIZED THE ELECTRODES WHEN GOING FROM THE SET-UP SCREEN TO THE MONITORING SCREEN. TO TROUBLESHOOT, THE USER RECONNECTED THE DEVICES, RECONNECTED THE PROBE AND ELECTRODES AND SWITCHED THE MAINFRAME OFF AND ON. IT WAS THE INITIAL USE OF THE ELECTRODES AND PROBE.
Patient 1
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.