FDA Adverse Event
Injury
Summary report: N
EXTERNAL TEMPORARY PACEMAKER
MDR report key: 3861150
·
Received June 10, 2014
Report
- Report Number
- 2183613-2010-00021
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- September 25, 2009
- Report Date
- November 25, 2024
- Manufacturer
- MEDTRONIC MILACA, INC.
- Product Code
- LWP
- PMA / PMN Number
- P820003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 344403 | EXTERNAL TEMPORARY PACEMAKER | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | MEDTRONIC MILACA, INC. | 5348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |