FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3213046
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09036
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- June 5, 2013
- Report Date
- June 5, 2013
- Manufacturer
- CPI PLANT - ST. PAUL
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 ONE DAY POST IMPLANT THIS RIGHT VENTRICULAR (RV) LEAD DISLODGED. AN REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311906 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI PLANT - ST. PAUL | 0696 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |