FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1873741
·
Received October 19, 2010
Report
- Report Number
- 2124215-2010-17206
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- August 19, 2010
- Report Date
- August 27, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD WAS ELECTRICALLY ABANDONED; THEREFORE THE COMPANY WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS SUSPECTED OF HAVING A CONDUCTOR FRACTURE AS IT EXHIBITED IMPEDANCES GREATER THAN 2000 OHMS. THE LEAD WAS ELECTRICALLY ABANDONED AS THE DEVICE WAS PROGRAMMED TO VVI MODE. TECHNICAL SERVICES (TS) ASSISTED THE CLINICIAN IN TURNING OFF ATRIAL SENSING AND ATRIAL DAILY MEASUREMENTS. 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 | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | 4087| 1861| E110| 0148 |