FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2910195
·
Received January 11, 2013
Report
- Report Number
- 2124215-2012-14818
- Event Type
- Injury
- Date Received
- January 11, 2013
- Date of Event
- October 30, 2012
- Report Date
- November 21, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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.
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION THIS SYSTEM REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. POST PROCEDURE, ACCEPTABLE MEASUREMENTS WERE OBTAINED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT REMOTE MONITORING REVEALED A HIGH SHOCK IMPEDANCE MEASUREMENT. THIS INFORMATION WAS SHARED WITH THE PHYSICIAN AND IS BEING FURTHER MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17094 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | 1852| 0161| F102 |