MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,company representati report with the FDA on 2015-01-23 for NIM RESPONSE? 8252001 manufactured by Medtronic Xomed, Inc.
[18662366]
It was reported that the device will be sent in for repair for an unknown malfunction. Attempts to obtain any additional information from the customer have been unsuccessful. There was no patient impact reported.
Patient Sequence No: 1, Text Type: D, B5
[18862973]
(b)(4). The product has not been received for analysis. Method: no testing methods performed.
Patient Sequence No: 1, Text Type: N, H10
[101901579]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2015-00021 |
| MDR Report Key | 4447601 |
| Report Source | 01,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-01-23 |
| Date of Report | 2014-12-30 |
| Date Mfgr Received | 2014-12-30 |
| Device Manufacturer Date | 2006-01-24 |
| Date Added to Maude | 2015-02-27 |
| 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 | AMY CORRALES |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328138 |
| 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 | NIM RESPONSE? |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2015-01-23 |
| Model Number | 8252001 |
| Catalog Number | 8252001 |
| Lot Number | 42468900 |
| 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 | 2015-01-23 |