FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3213708
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09246
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- April 19, 2013
- Report Date
- April 22, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. THE PHYSICIAN HAD TROUBLE REMOVING THE HELIX USING THE CONNECTOR TOOL. THIS LEAD WAS REPOSITIONED SUCCESSFULLY AND REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314451 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |