FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1864087
·
Received October 11, 2010
Report
- Report Number
- 2124215-2010-15895
- Event Type
- Injury
- Date Received
- October 11, 2010
- Date of Event
- August 4, 2010
- Report Date
- August 4, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AS NECESSARY.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD DISLODGED. A REPOSITION SURGERY WAS SUCCESSFUL AND THE LEAD IS NOW WORKING APPROPRIATELY. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS 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 | 72 YR | Required Intervention | S606| 4088| 4087 |