FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1946199
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-20678
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- October 15, 2010
- Report Date
- October 15, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD WAS SURGICALLY ABANDONED AND THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO IMPEDANCES MEASUREMENTS THAT WERE CONSISTENTLY GREATER THAN 2,500 OHMS. SINCE THE PATIENT HAS BEEN ABLE TO TOLERATE THE HIGH IMPEDANCE MEASUREMENTS ON THE RA LEAD WITH NO ADVERSE EFFECTS, THE PHYSICIAN ELECTED TO REPLACE THE CURRENT DEVICE WITH A SINGLE CHAMBER PACEMAKER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AND THE INVESTIGATION IS COMPLETE.
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 | 96 YR | Hospitalization| L| R | 1286| 4087| S201| 4455 |