FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1873882
·
Received October 19, 2010
Report
- Report Number
- 2124215-2010-17444
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- August 31, 2010
- Report Date
- August 31, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT 25 DAYS POST IMPLANT, THE RIGHT ATRIAL (RA) LEAD DISLODGED AND WAS SUCCESSFULLY REPOSITIONED. THE RA LEAD REMAINS IN SERVICE AND YIELDED GOOD MEASUREMENTS AFTER BEING REPOSITIONED. 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 | 4086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| L| R | 4555| 4086| 0158| N119 |