N
Patient 1
ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9829706
- MDR report key
- 9829706
- Report number
- 1045254-2020-00156
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-19
- Date received
- 2020-03-13
- 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-ECLIPSE? PREAMPLIFIER | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | MEDTRONIC XOMED INC. | GWF | DAQ916 | DAQ916 | 206687213 | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-13 | 0 |
Event Narratives#
D
Patient 1
A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE DEVICE NEEDS REPAIR. THERE WAS NO PATIENT IMPACT.