FDA Adverse Event
Injury
Summary report: N
PERV. VENT. LINEAR BIPOLAR
MDR report key: 1011040
·
Received March 10, 2008
Report
- Report Number
- 2017865-2008-00768
- Event Type
- Injury
- Date Received
- March 10, 2008
- Date of Event
- January 7, 2008
- Manufacturer
- TELECTRONICS PACING SYSTEMS
- Product Code
- DTB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- NURSE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERV. VENT. LINEAR BIPOLAR | PERMANENT PACEMAKER ELECTRODE | DTB | TELECTRONICS PACING SYSTEMS | 325-161 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |