FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND II
MDR report key: 2151082
·
Received July 6, 2011
Report
- Report Number
- 2124215-2011-06048
- Event Type
- Malfunction
- Date Received
- July 6, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 5, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, 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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. SENSING AND SHOCKING IMPEDANCE MEASUREMENTS WERE NORMAL AND WITHIN RANGE. NO INAPPROPRIATE THERAPY WAS DELIVERED AND PATIENT DID NOT EXPERIENCE ASYSTOLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |