FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3223533
·
Received July 12, 2013
Report
- Report Number
- 2124215-2013-10340
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- June 21, 2013
- Report Date
- June 25, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN
- 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 A ROUTINE DEVICE CHECK, THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH, OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WITH HIGH PACING THRESHOLD MEASUREMENTS. A SURGICAL INTERVENTION WAS PERFORMED WHERE THIS LEAD WAS PARTIALLY ABANDONED AND CAPPED. A NEW RV LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324004 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| L| R | 4469| 4087| 1298 |