FDA Adverse Event
Injury
Summary report: N
FINELINE
MDR report key: 1041689
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34960
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 26, 2008
- Report Date
- March 26, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4450 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention | THE DEVICE 1270/619475 WAS IMPLANTED 27-JUN-2000| THE DEVICE 1297/318344 WAS IMPLANTED 26-MAR-2008| THE DEVICE 4136/282810 WAS IMPLANTED 26-MAR-2008| THE DEVICE 4271/223769 WAS IMPLANTED 27-JUN-2000 |