FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE SG
MDR report key: 3040912
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-03738
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- February 20, 2013
- Report Date
- February 29, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- PMA / PMN Number
- P910073/S043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144296 | ENDOTAK RELIANCE SG | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | 0181 | 305397 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male | Required Intervention| H| L |