FDA Adverse Event
Injury
Summary report: N
POLYFLEX
MDR report key: 1042373
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34272
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 5, 2008
- Report Date
- March 5, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYFLEX | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 480-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention | THE DEVICE 1270/660642 WAS IMPLANTED 25-MAY-2001| THE DEVICE 366-/01213C WAS IMPLANTED 09-JUN-1994| THE DEVICE 4136/282578 WAS IMPLANTED 06-MAR-2008| THE DEVICE 4269/212442 WAS IMPLANTED 09-JUN-1994| THE DEVICE 480-/02764B WAS IMPLANTED 24-JUN-1987 |