MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-01-20 for NIM? 2.0 INTERFACE 8252200 manufactured by Medtronic Xomed Inc..
[65384080]
The product was returned for analysis. Pre-repair inspection confirmed the reported event of no stimulation response and found a broken cable. Device evaluation not yet complete, completion of evaluation anticipated. 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 Sequence No: 1, Text Type: N, H10
[65384081]
It was reported that before the procedure there was no stimulation response from the device. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[71277768]
Device evaluation has been completed. Analysis confirmed the reported event of no stimulation response. The device was not repaired. The customer replaced their device with a new device.
Patient Sequence No: 1, Text Type: N, H10
[71277769]
Additional information received indicated that the nerve location known, but the device was not detecting it. The system did not alert the user of the issue. When going from the set-up to the monitoring screen the device was recognizing the electrodes.
Patient Sequence No: 1, Text Type: D, B5
[96981746]
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 Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2017-00033 |
| MDR Report Key | 6266408 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-01-20 |
| Date of Report | 2016-12-26 |
| Date of Event | 2016-12-22 |
| Date Mfgr Received | 2017-03-28 |
| Device Manufacturer Date | 2009-03-06 |
| Date Added to Maude | 2017-01-20 |
| 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 | SHARANYA JANGITI |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328183 |
| 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? 2.0 INTERFACE |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2017-01-20 |
| Returned To Mfg | 2016-12-26 |
| Model Number | 8252200 |
| Catalog Number | 8252200 |
| Lot Number | 60601100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-01-20 |