FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE G
MDR report key: 8563787
·
Received April 30, 2019
Report
- Report Number
- 2124215-2019-08078
- Event Type
- Injury
- Date Received
- April 30, 2019
- Date of Event
- February 6, 2019
- Report Date
- April 30, 2019
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVY
- UDI-DI
- 00802526431418
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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
IT WAS REPORTED THE RV LEAD (0286 /014113) WAS EXPLANTED BECAUSE OF HIGH STIMULUS THRESHOLD VALUES, AND REPLACED WITH ANOTHER LEAD OF A DIFFERENT MODEL (0293). THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED AT THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360032 | ENDOTAK RELIANCE G | PERMANENT DEFIBRILLATOR ELECTRODES | NVY | BOSTON SCIENTIFIC CORPORATION | 0286 | 014113 | 00802526431418 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |