MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,06 report with the FDA on 2013-06-28 for DEVICE 8252200 NIM-RESPONSE 2.0 INTERFAC manufactured by Medtronic Xomed, Inc..
[21293183]
It was reported the box has to be situated in the right position in order to work; works intermittently.
Patient Sequence No: 1, Text Type: D, B5
[21483320]
This device is used for therapeutic purposes. (b)(4). The returned device was evaluated by quality engineer. The mainframe was powered on with the interface, simulator, and probe c onnected. A monitoring mode using all available channels was selected. Each channel was stimulated in turn using stim 1 and stim 2; proper responses and measured currents were seen on any channels with each stim circuit. However, a muting warning intermittently appeared. The interface was unplugged and then plugged back in. The electrode check did not pick up any impedance readings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00436 |
| MDR Report Key | 3195741 |
| Report Source | 03,06 |
| Date Received | 2013-06-28 |
| Date of Report | 2013-06-03 |
| Date Mfgr Received | 2013-06-03 |
| Device Manufacturer Date | 2005-07-14 |
| Date Added to Maude | 2013-08-02 |
| 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 | 0 |
| Event Location | 0 |
| 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 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 8252200 NIM-RESPONSE 2.0 INTERFAC |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2013-06-28 |
| Returned To Mfg | 2013-06-07 |
| Model Number | 8252200 |
| Catalog Number | 8252200 |
| Lot Number | 39290600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-28 |