FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 6237812
·
Received January 10, 2017
Report
- Report Number
- 2124215-2016-17533
- Event Type
- Malfunction
- Date Received
- January 10, 2017
- Date of Event
- October 12, 2016
- Report Date
- October 13, 2016
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- UDI-DI
- 00802526531248
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT WAS BROUGHT INTO THE CLINIC FOR AN IN OFFICE IMPEDANCE CHECK. THE ROOT CAUSE OF THE REPORTED CLINICAL OBSERVATIONS WAS NOT IDENTIFIED. 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 SYSTEM EXHIBITED A SHOCK IMPEDANCE MEASUREMENT OF 125 OHMS. A REVIEW OF THE DATA SHOWED THE MEASUREMENTS HAVE BEEN BETWEEN 100-125 OHMS OVER THE PAST THREE MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19799 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0292 | 00802526531248 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | 0292| 4135| E162 |