FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3210350
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-09180
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 22, 2013
- Report Date
- April 22, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RETURN OF THE PRODUCT IS NOT EXPECTED AS IT WAS DISCARDED BY HOSPITAL STAFF. 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 LASER EXTRACTION OF THE RIGHT VENTRICULAR (RV) LEAD, THIS RIGHT ATRIAL (RA) LEAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310475 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| L| R | 0180| 0174| E110| 4135| 4086 |