FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3911713
·
Received July 3, 2014
Report
- Report Number
- 2124215-2014-10708
- Event Type
- Injury
- Date Received
- July 3, 2014
- Date of Event
- April 22, 2014
- Report Date
- April 22, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 AS OBSERVED VIA FLUOROSCOPY. ADDITIONAL INFORMATION REVEALED THE LEAD WAS REPOSITIONED SUCCESSFULLY. THE RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 391415 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization| L| R | E142| 1882TC| 0296 |