MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-30 for NIM? PROBE 8225101 manufactured by Medtronic Xomed Inc..
[185800242]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185800243]
A health care provider (hcp) reported via a distributor that when the doctor used the probe during a parotidectomy procedure, he found that detection was not sensitive. Sometimes there was a response and sometimes there was no response. After several tests, it did not improve. There was a delay of 5 minutes in the procedure as a result of this event. The procedure was completed using a back-up device. There was no intervention planned or performed. The patient was alive with no injury. On follow-up, it was reported that there was no visual and/or audible indicators that alerted the user of the issue. The doctor judged that the device was malfunctioning. The current stim return value displayed was not "0", for troubleshooting, the doctor tried to reconnect the probe and restart the nerve monitor but both were useless. On follow-up, it was reported that detection of insensitivity improved after the doctor changed the probe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00190 |
| MDR Report Key | 9897739 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-03-20 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIM? PROBE |
| Generic Name | STIMULATOR, NERVE |
| Product Code | ETN |
| Date Received | 2020-03-30 |
| Model Number | 8225101 |
| Catalog Number | 8225101 |
| Lot Number | 0217329506 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |