N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9881837
- MDR report key
- 9881837
- Report number
- 1045254-2020-00185
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-03
- Date received
- 2020-03-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- CHRISTY CAIN
- Address
- 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US
- Phone
- 904-904-9043
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NIM-NEURO? 3.0 MAINFRAME | STIMULATOR, NERVE | MEDTRONIC XOMED INC. | ETN | 8253402 | 8253402 | 206064541 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-26 | 0 |
Event Narratives#
D
Patient 1
A HEALTHCARE PROVIDER (HCP) REPORTED THAT A NERVE MONITORING DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.