FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3241470
·
Received July 22, 2013
Report
- Report Number
- 2124215-2013-11427
- Event Type
- Injury
- Date Received
- July 22, 2013
- Date of Event
- June 13, 2013
- Report Date
- June 13, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- 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 ATRIAL (RA) LEAD EXHIBITED OVERSENSING BUT THERE WAS NO REPORT OF PACING INHIBITION. A REVISION PROCEDURE WAS DONE TO SURGICALLY ABANDON THE LEAD. ADDITIONAL INFORMATION WAS RECEIVED THAT THE OVERSENSING WAS DUE TO LEAD FRACTURE. THIS RA LEAD IS NO LONGER IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340065 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| L| R | 4086| 1823| 4135| 4524| 4513| 0125| H215| H175| H219| N164 |