FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3041270
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-01814
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- January 16, 2013
- Report Date
- January 31, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD IMPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THE DEVICE REMAINS IN SERVICE. 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 A HIGH OUT OF RANGE PACING IMPEDANCE AND THE THRESHOLDS HAVE RISEN. SOME OVERSENSING WAS ALSO NOTED. THE PHYSICIAN WILL ADDRESS THE ISSUE IN THE COMING DAYS.THE PATIENT IS NOT PACER DEPENDENT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142790 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Hospitalization| L| R | S606| 1290| 4086| 4087 |