FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3936156
·
Received July 15, 2014
Report
- Report Number
- 2124215-2014-13686
- Event Type
- Malfunction
- Date Received
- July 15, 2014
- Date of Event
- June 14, 2014
- Report Date
- June 15, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCKING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. ADDITIONAL INFORMATION WAS RECEIVED AND INDICATED THAT THE CAUSE WAS NOT CONCLUSIVELY DETERMINED. NO INTERVENTION WAS PERFORMED AT THIS TIME. THE PATIENT WOULD CONTINUE TO BE MONITORED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 412680 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | 4543| N140| 4135| 0292 |