FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1952236
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-23563
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- November 29, 2010
- Report Date
- November 29, 2010
- 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
THE LEAD WAS CAPPED AND SURGICALLY ABANDONED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL PACING LEAD EXHIBITED IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS. AN INVASIVE PROCEDURE WAS PERFORMED AND IT WAS NOTED THAT THE LEAD HAD FRACTURED UNDER THE CLAVICLE. 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 | 90 YR | Required Intervention | 1290| S606| 4135| 4086| 4087 |