FDA Adverse Event
Injury
Summary report: N
LASERPOR 030-236
MDR report key: 77025
·
Received March 15, 1997
Report
- Report Number
- 1316542-1997-00522
- Event Type
- Injury
- Date Received
- March 15, 1997
- Date of Event
- August 23, 1996
- Report Date
- March 14, 1997
- Manufacturer
- TELECTRONICS PACING SYSTEMS
- Product Code
- DTB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE LEAD WAS CUT & CAPPED DUE TO A REPORT OF LEAD LOSS OF SENSING AND CAPTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LASERPOR 030-236 Implant | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE | DTB | TELECTRONICS PACING SYSTEMS | 030-236 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |