FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1853499
·
Received October 5, 2010
Report
- Report Number
- 2124215-2010-14756
- Event Type
- Injury
- Date Received
- October 5, 2010
- Date of Event
- July 19, 2010
- Report Date
- July 22, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
THIS LEAD WAS SURGICALLY ABANDONED; THEREFORE WE 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 RIGHT VENTRICULAR LEAD TRIPPED THE LEAD SAFETY SWITCH DUE TO LOW IMPEDANCE MEASUREMENTS. DURING TESTING, NOISE WAS OVERSENSED RESULTING IN INHIBITION OF THERAPY. THE NOISE WAS OBSERVED WHEN THE PATIENT TOOK DEEP BREATHS.
Description of Event or Problem · 1
INFORMATION WAS LATER RECEIVED THAT THIS LEAD WAS SURGICALLY ABANDONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Life Threatening | 4087| 4088| 1291 |