FDA Adverse Event
Malfunction
Summary report: N
VITALITY EL
MDR report key: 1042169
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34487
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 17, 2008
- Report Date
- March 17, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY EL | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T127 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other | THE DEVICE 6481 310715 WAS USED DURING THE EVENT.| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 4462/100173 WAS IMPLANTED 05-JUL-2000| THE DEVICE 1831/113094 WAS IMPLANTED 05-JUL-2000| THE DEVICE 0155/340519 WAS IMPLANTED 05-JUL-2000 |