FDA Adverse Event
Injury
Summary report: N
DEXATIP VENTRICULAR BIPOLAR PACING LEAD
MDR report key: 26225
·
Received August 17, 1995
Report
- Report Number
- 2124215-1995-00062
- Event Type
- Injury
- Date Received
- August 17, 1995
- Report Date
- August 16, 1995
- Manufacturer
- MEDTRONIC
- Product Code
- DTB
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
RECEIVED INFORMATION THAT A PT WITH AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM EXPERIENCED POOR SENSING AND PACING TWO DAYS POST IMPLANT. INVASIVE ANALYSIS WAS PERFORMED AND THIS BIPOLAR LEAD AND A MODEL 4269 LEAD, SERIAL NUMBER 231525, WERE REMOVED FROM SERVICE BECAUSE OF SUSPECTED INSULATION PROBLEMS. A SERIOUS INJURY REPORT WAS SUBMITTED ON THE 4269 LEAD ON 8/16/95.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEXATIP VENTRICULAR BIPOLAR PACING LEAD | BIPOLAR LEAD | DTB | MEDTRONIC | 4262 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |