FDA Adverse Event
Injury
Summary report: N
2124215-2011-10765
MDR report key: 2170287
·
Received July 20, 2011
Report
- Report Number
- 2124215-2011-10765
- Event Type
- Injury
- Date Received
- July 20, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 1, 2011
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS RV LEAD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT, WHO HAS THIS RIGHT VENTRICULAR (RV) LEAD, DEVELOPED A POCKET INFECTION. THE PHYSICIAN OPENED THE POCKET TO PERFORM A SYSTEM REVISION, AND DURING ELECTROCAUTERY DAMAGED THE INSULATION OF THIS RV LEAD. THE RV LEAD'S INSULATION WAS REPAIRED, AND THE INFECTION WAS TREATED WITH A MEDICAL SOLUTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NVY | GUIDANT PUERTO RICO BV | TACHY LEAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |