FDA Adverse Event
Injury
Summary report: N
LEAD ENGUARD BIF PF DFT 100
MDR report key: 82604
·
Received April 8, 1997
Report
- Report Number
- 1316542-1997-00714
- Event Type
- Injury
- Date Received
- April 8, 1997
- Report Date
- March 28, 1997
- Manufacturer
- TELECTRONICS PACING SYSTEMS
- Product Code
- DTB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORT RECEIVED OF LEAD DISLODGEMENT. LEAD WAS SUCCESSFULLY REPOSITIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD ENGUARD BIF PF DFT 100 Implant | CARDIOVASCULAR PERMANENT ELECTRODE | DTB | TELECTRONICS PACING SYSTEMS | 040-068 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |