FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3213037
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10041
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- June 7, 2013
- Report Date
- June 7, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMTTENT CAPTURE AND OVERSENSING DUE TO NOISE. THE LEAD WAS SURGICALLY ABANDONED AND A NEW RV LEAD IMPLANTED WITHOUT ISSUE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313498 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| L| R | 1290| 4087| S603| 4136| 4086 |