FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3213550
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-07678
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- April 18, 2013
- Report Date
- April 18, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA
- 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 HAD FRACTURED. THE PHYSICIAN HAS SURGICALLY ABANDONED THE LEAD AND REPLACED WITH A NEW LEAD. THE RV LEAD IS NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312385 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| L| R | 4457| 1190| S601| 4088 |