FDA Adverse Event
Injury
Summary report: N
PROGRAMMER, PACEMAKER
MDR report key: 3070601
·
Received April 22, 2013
Report
- Report Number
- 2124215-2012-16615
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- December 12, 2012
- Report Date
- April 1, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KRG
- PMA / PMN Number
- P960040/S039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173202 | PROGRAMMER, PACEMAKER | KRG | BOSTON SCIENTIFIC CORPORATION | T177 | 107912 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening |