FDA Adverse Event
Injury
Summary report: N
ENDOTAK DSP
MDR report key: 2153570
·
Received July 7, 2011
Report
- Report Number
- 2124215-2011-07190
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- April 7, 2011
- Report Date
- April 7, 2011
- Manufacturer
- HISTORICAL PUERTO RICO
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT OF RANGE PACING IMPEDANCES AND NOISE. A LEAD REVISION PROCEDURE WAS PERFORMED WHERE THE LEAD WAS CUT AND CAPPED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK DSP | IMPLANTABLE LEAD | NVY | HISTORICAL PUERTO RICO | 0125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4) |