MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-10-10 for MAINFRAME 8252001 NIM-RESPONSE 2.0 manufactured by Medtronic Xomed, Inc..
[3886047]
It was reported that a nim response 2. 0 was having trouble getting emg responses intraoperatively during a parotidectomy. No patient impact or injury was reported as a result of either event. The device was no longer used in each event as soon as the issue became apparent and the doctor was able to successfully complete both surgeries relying on her expertise alone.
Patient Sequence No: 1, Text Type: D, B5
[11147724]
(b)(4): both devices were returned to medtronic? S (b)(4) location for evaluation and repair. Analysis found a broken solder joint on the aux stim of the patient interface, and which a cmos battery required in the mainframe? Both devices require calibration. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00535 |
| MDR Report Key | 3405350 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-10-10 |
| Date of Report | 2013-09-13 |
| Date Mfgr Received | 2013-09-13 |
| Device Manufacturer Date | 2005-02-22 |
| Date Added to Maude | 2014-01-13 |
| 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 | JACKLYN HAYMAN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042812769 |
| 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 8252001 NIM-RESPONSE 2.0 |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2013-10-10 |
| Returned To Mfg | 2013-09-26 |
| Model Number | 8252001 |
| Catalog Number | 8252001 |
| Lot Number | 37017200 |
| 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 | 2013-10-10 |