FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
MDR report key: 3071491
·
Received April 22, 2013
Report
- Report Number
- 2124215-2013-03658
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- February 12, 2013
- Report Date
- February 29, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- PMA / PMN Number
- P010012/S031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173201 | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | BOSTON SCIENTIFIC CORPORATION | H210 | 202322 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Male | Life Threatening| H| R |