FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3241481
·
Received July 22, 2013
Report
- Report Number
- 2124215-2013-10927
- Event Type
- Malfunction
- Date Received
- July 22, 2013
- Date of Event
- June 27, 2013
- Report Date
- July 11, 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.
Additional Manufacturer Narrative · 1
----
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF OOR SLI WAS NOT DETERMINED. THEY PLANNED TO CONTINUE MONITORING THE PATIENT. LEAD INTEGRITY TEST WAS NOT PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE (SLI) WHICH WAS DETECTED VIA PATIENT'S REMOTE MONITORING SYSTEM. THERE WERE NO REPORTS OF OTHER LEAD MEASUREMENT OR PATIENT HARM. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341542 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | E140| 0293 |