MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2013-12-30 for MAINFRAME 8252401IP NEURO 2.0 W/INCRE manufactured by Medtronic Xomed, Inc..
[3981583]
It was reported by facility? S biomed department, the nim response 2. 0 keeps increasing the stimulus automatically whether user has the incrementing probe plugged in or not. Facility tried unplugging the patient interface box and rebooting system, issue persisted. Stimulus keeps increasing to 30ma.
Patient Sequence No: 1, Text Type: D, B5
[11478508]
This device is used for therapeutic purposes. (b)(4). Product has not been returned for evaluation by manufacturer. Method - no testing methods performed.
Patient Sequence No: 1, Text Type: N, H10
[102471997]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00616 |
| MDR Report Key | 3542506 |
| Report Source | 06,USER FACILITY |
| Date Received | 2013-12-30 |
| Date of Report | 2013-12-03 |
| Date Mfgr Received | 2013-12-03 |
| Device Manufacturer Date | 2007-09-27 |
| Date Added to Maude | 2014-04-03 |
| 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 | 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 | MAINFRAME 8252401IP NEURO 2.0 W/INCRE |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2013-12-30 |
| Model Number | 8252401IP |
| Catalog Number | 8252401IP |
| Lot Number | 52565900 |
| 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 DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-30 |