FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 2050360
·
Received April 12, 2011
Report
- Report Number
- 2124215-2011-03291
- Event Type
- Injury
- Date Received
- April 12, 2011
- Date of Event
- February 20, 2011
- Report Date
- February 17, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL SALES REPRESENTATIVE THAT THIS RIGHT ATRIAL (RA) LEAD HAD DISLODGED WHEN THE LEFT VENTRICULAR LEAD WAS IMPLANTED. A REVISION WAS SUCCESSFULLY COMPLETED ON THIS RA LEAD. NO ADVERSE PATIENT EFFECTS 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 | 74 YR | Required Intervention | 0157| N119| 4046| 4086 |