FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2910723
·
Received January 11, 2013
Report
- Report Number
- 2124215-2012-16244
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Date of Event
- November 19, 2012
- Report Date
- November 19, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING AND SHOCK IMPEDANCE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED PERFORMING ISOMETRICS. THE FIELD REPRESENTATIVE STATED THAT DURING THE INTERROGATION OF THE NON-BOSTON SCIENTIFIC DEVICE, THERE WAS NO NOISE SEEN AND NOISE WAS NOT REPRODUCIBLE WITH ISOMETRICS. THE FIELD REPRESENTATIVE WAS UNAWARE AND UNABLE TO OBTAIN RESOLUTION TO THIS ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19120 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | T175| MISMATCH| 0180 |