FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3053244
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05142
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- March 18, 2013
- Report Date
- March 18, 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 DISPLAYED A LOW, OUT OF RANGE PACE IMPEDANCE MEASUREMENT WHICH WAS DETECTED VIA THE PATIENT'S REMOTE HOME MONITORING SYSTEM. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS IN CONTACT WITH THE PATIENT'S CLINIC BUT WAS UNAWARE OF ANY ADDITIONAL INFORMATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154587 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | N119| 4591| 1888TC| 0158 |