FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3210979
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-09460
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 5, 2013
- Report Date
- April 26, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- 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.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. THE SYSTEM REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310600 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 307 MO | 0292| E140 |