FDA Adverse Event
Injury
Summary report: N
CARDIAC PACEMAKERS, INC.
MDR report key: 24220
·
Received January 25, 1995
Report
- Report Number
- 24220
- Event Type
- Injury
- Date Received
- January 25, 1995
- Date of Event
- November 29, 1993
- Report Date
- November 30, 1993
- Manufacturer
- CARDIAC PACEMAKERS, INC.
- Product Code
- DRK
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AICD WAS CHANGED DUE TO INAPPROPRIATE SHOCKS BEING DELIVERED TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDIAC PACEMAKERS, INC. Implant | AUTOMATIC IMPLANTABLE CARDIO-DEEFIBRILLATOR | DRK | CARDIAC PACEMAKERS, INC. | 1600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization |