FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3922048
·
Received July 9, 2014
Report
- Report Number
- 2124215-2014-13548
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- June 25, 2014
- Report Date
- June 25, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- 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 RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED. THE PHYSICIAN HAD IT REPOSITIONED AND THE LEAD HAD GOOD MEASUREMENTS AFTER. RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401997 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization| L| R | 4136| 0295| E162 |