MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-12-30 for DEVICE 8252410 NIM-NEURO 2.0 INTERFACE manufactured by Medtronic Xomed, Inc..
[4100471]
It was reported the patient interface was working intermittently. No report of patient impact.
Patient Sequence No: 1, Text Type: D, B5
[11475638]
This device is used for therapeutic purposes. No known impact or consequence to patient. (b)(4). Loose or intermittent connection. (b)(4). The returned device was tested, and found cable failure. Replaced cable and decal the unit was cleaned, tested and passed all manufacturing specifications. Results: signal loss. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00614 |
| MDR Report Key | 3542168 |
| Report Source | 00 |
| Date Received | 2013-12-30 |
| Date of Report | 2013-12-04 |
| Date of Event | 2013-12-03 |
| Date Mfgr Received | 2013-12-04 |
| Device Manufacturer Date | 2006-04-19 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 8252410 NIM-NEURO 2.0 INTERFACE |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2013-12-30 |
| Returned To Mfg | 2013-12-08 |
| Model Number | 8252410 |
| Catalog Number | 8252410 |
| Lot Number | 44179800 |
| 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 | 2013-12-30 |