FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3910483
·
Received July 2, 2014
Report
- Report Number
- 2124215-2014-09723
- Event Type
- Injury
- Date Received
- July 2, 2014
- Date of Event
- April 8, 2014
- Report Date
- April 8, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND
- 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 WAS DISLODGED. ADDITIONAL INFORMATION REVEALED THIS RV LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 388041 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| L| R | E142| 0275| 4469 |