FDA Adverse Event
Malfunction
Summary report: N
FLEXTEND II
MDR report key: 2171255
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-09746
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 6, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS THERE WILL BE RETURN OF PRODUCT, BOSTON SCIENTIFIC CANNOT CONFIRM NOR DENY THIS REPORTED CLINICAL ALLEGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD DISPLAYED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. A LEAD FRACTURE WAS SUSPECTED. DURING A DEVICE REPLACEMENT PROCEDURE (CONTAK RENEWAL MODEL H230 SN (B)(4)), THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND II | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other | 0165| H230| 4543| 4096 |