FDA Adverse Event
Injury
Summary report: N
ENDOTAK DSP
MDR report key: 2922878
·
Received January 18, 2013
Report
- Report Number
- 2124215-2012-06876
- Event Type
- Injury
- Date Received
- January 18, 2013
- Date of Event
- May 2, 2012
- Report Date
- April 1, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- PMA / PMN Number
- P910073/S015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28688 | ENDOTAK DSP | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | 0095 | 200654 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Life Threatening |