FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 2171566
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-11417
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- June 3, 2011
- Report Date
- June 3, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS SURGICALLY ABANDONED AND WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS. ADDITIONALLY, OVERSENSING WAS NOTED. A LEAD REVISION WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | 4137| 4087| 1298| S603| 4088 |