FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 2053069
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04161
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- March 2, 2011
- Report Date
- March 9, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
THE PRODUCT HAS NOT BEEN RETURNED. IF RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD EXHIBITED NOISE AND IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS. IT WAS DETERMINED THE LEAD WAS FRACTURED. THE DEVICE WAS PROGRAMMED TO VVI MODE. NO ADVERSE PATIENT EFFECTS WERE NOTED.
Description of Event or Problem · 1
INFORMATION WAS LATER RECEIVED THAT THIS LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE PROCEDURE.
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 | 62 YR | Required Intervention | T165| 0157| 4087| T125 |