FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1951535
·
Received January 6, 2011
Report
- Report Number
- 2124215-2010-23209
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- November 24, 2010
- Report Date
- November 24, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD EXHIBITED A LOSS OF CAPTURE. AN X-RAY WAS PERFORMED AND CONFIRMED THAT THE LEAD HAD DISLODGED. A LEAD REVISION WAS PERFORMED. ALL DIAGNOSTICS ARE WITHIN RANGE AFTER THE LEAD WAS REPOSITIONED. ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention | 4087| E110| 0185 |