FDA Adverse Event
Malfunction
Summary report: N
VITALITY AVT FAST-CHARGE
MDR report key: 1042834
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33809
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 25, 2008
- Report Date
- February 25, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY AVT FAST-CHARGE | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | A155 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other | THE DEVICE 0145/337287 WAS IMPLANTED 17-JUL-2000| THE DEVICE 1851/307768 WAS IMPLANTED 17-JUL-2000| THE DEVICE 4538/166683 WAS IMPLANTED 03-APR-2008| THE DEVICE 4271/226206 WAS IMPLANTED 17-JUL-2000| THE DEVICE 4087/226173 WAS IMPLANTED 18-NOV-2004 |