FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3223552
·
Received July 12, 2013
Report
- Report Number
- 2124215-2013-09909
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- June 20, 2013
- Report Date
- June 20, 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
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 DURING DEVICE CHANGEOUT, THIS RIGHT ATRIAL (RA) LEAD WAS OBSERVED TO BE FRACTURED AND EXHIBITED HIGH, OUT OF RANGE PACING IMPEDANCE MEASUREMENT. THIS LEAD WAS SURGICALLY ABANDONED AND CAPPED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323466 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Hospitalization| L| R | 0159| E141| T125| 0158| T180| 4087 |