FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3213106
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09775
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- March 18, 2013
- Report Date
- June 3, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LEAD REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS RECEIVED FOR THIS SYSTEM DUE TO A LOW SHOCKING IMPEDANCE MEASUREMENT. A REVIEW OF THE DAILY MEASUREMENTS CONFIRMED NORMAL MEASUREMENT IN THE 50-60 OHMS RANGE OVER THE PAST YEAR WITH ONLY ONE MEASUREMENT WHICH WAS OUT OF RANGE. THE PHYSICIAN HAS CHOSEN TO HAVE THE PATIENT WAIT FOR THEIR NORMAL FOLLOW UP. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312181 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | 4525| 4087| H179| H219| N164| 0158 |