FDA Adverse Event
Malfunction
Summary report: N
INTERVENE
MDR report key: 2277332
·
Received October 5, 2011
Report
- Report Number
- 2124215-2011-12248
- Event Type
- Malfunction
- Date Received
- October 5, 2011
- Date of Event
- July 12, 2011
- Report Date
- July 12, 2011
- Manufacturer
- GUIDANT ANGLETON/ST. PAUL
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ALERT WAS DETECTED DUE TO HIGH RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD SHOCK IMPEDANCE MEASUREMENTS. NO REVISION HAS BEEN SCHEDULED AS THE PHYSICIAN HAS ELECTED TO MONITOR THE LEAD AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERVENE | IMPLANTABLE LEAD | NVY | GUIDANT ANGLETON/ST. PAUL | 497-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | 1861| N119| 7304| (B)(4)| (B)(4)| (B)(4)| 4193| 4470 |