MAUDE MDR 9225453
- MDR report key
- 9225453
- Report number
- 9225453
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-10-01
- Date received
- 2019-10-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | TEMPO TEMPORARY PACING LEAD | TEMPORARY PACEMAKER WIRE | BIOTRACE MEDICAL, INC. | LDF | | | 31140 | | | | I
| Y |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2019-10-23 | 0 | 1. O
|
Event Narratives#
No narrative records found.