FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3043271
·
Received April 9, 2013
Report
- Report Number
- 2124215-2013-03875
- Event Type
- Injury
- Date Received
- April 9, 2013
- Date of Event
- January 25, 2013
- Report Date
- January 25, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE AVAILABLE FOR RETURN. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT PRESENTED WITH SYMPTOMS OF PALPITATIONS AND "FEELING STRANGE". DURING LEAD EVALUATION OUT OF RANGE IMPEDANCE MEASUREMENTS AND HAD REPRODUCIBLE NOISE THAT WAS BEING OVERSENSED. A LEAD REVISION WAS PERFORMED TO REPLACE THE LEAD. THERE WERE NO ADVERSE PATIENT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 147194 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Life Threatening| R | 4087| 0184| 4136| 4543| H227| T165 |