FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2905480
·
Received January 9, 2013
Report
- Report Number
- 2124215-2012-13467
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- October 2, 2012
- Report Date
- October 16, 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
ADDITIONAL INFORMATION WAS RECEIVED THAT THE REMOTE HOME MONITORING SYSTEM ISSUED ANOTHER ALERT FOR INTERMITTENT LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LOW SHOCK IMPEDANCE MEASUREMENT OF LESS THAN 20 OHMS WAS DETECTED ON THIS RIGHT VENTRICULAR LEAD. THE IMPEDANCES HAVE SINCE BEEN REVIEWED AND ARE BACK TO NORMAL LEVELS. NO OTHER ISSUES WERE NOTED, AND THE PATIENT WILL BE SEEN AT A NORMAL FOLLOW UP IN THE NEAR FUTURE TO FURTHER INVESTIGATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12116 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | E160| 0296 |