FDA Adverse Event
Injury
Summary report: N
CARDIAC PACEMAKERS, INC.
MDR report key: 228023
·
Received June 15, 1999
Report
- Report Number
- 228023
- Event Type
- Injury
- Date Received
- June 15, 1999
- Date of Event
- May 13, 1999
- Report Date
- June 14, 1999
- Manufacturer
- CARCIAC PACEMAKERS, INC.
- Product Code
- DXY
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NE, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DESCRIBE EVENT OR PROBLEM: ON ALERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDIAC PACEMAKERS, INC. Implant | GENERATOR | DXY | CARCIAC PACEMAKERS, INC. | 1276 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization| R |