FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 2922606
·
Received January 18, 2013
Report
- Report Number
- 2124215-2012-13141
- Event Type
- Injury
- Date Received
- January 18, 2013
- Date of Event
- July 11, 2012
- Report Date
- April 1, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DTB
- PMA / PMN Number
- P960006/S005
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28689 | FLEXTEND | PERMANENT PACEMAKER ELECTRODE | DTB | BOSTON SCIENTIFIC CORPORATION | 4086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Male | Life Threatening |