MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2014-02-21 for DEVICE 8252410 NIM-NEURO 2.0 INTERFACE manufactured by Medtronic Xomed Inc..
[17159741]
It was reported that the patient interface has an intermittent connection when the cable is bumped. It was confirmed with physician that the device was making strange, unexpected noises. It has also been confirmed that monitoring would stop, and after manipulation of the interface box, would start up again. The physician reverted to clinical judgment for the remainder of the procedure, there was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[17621158]
This device is used for therapeutic purposes. Concomitant medical products: 8252401, mainframe 8252401 nim-neuro 2. 0, s/n (b)(4), lot: 39240600. 510k: k024316. Manufactured july 21, 2005. (b)(4). Product evaluation: the facility has confirmed that the device has been taken out of service due to age; it will not be returned for analysis. Method: no testing methods performed.
Patient Sequence No: 1, Text Type: N, H10
[101907936]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2014-00041 |
| MDR Report Key | 3640020 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2014-02-21 |
| Date of Report | 2014-01-27 |
| Date of Event | 2014-01-27 |
| Date Mfgr Received | 2014-01-27 |
| Date Added to Maude | 2014-05-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| 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 | DEVICE 8252410 NIM-NEURO 2.0 INTERFACE |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2014-02-21 |
| Model Number | 8252410 |
| Catalog Number | 8252410 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-21 |