FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3040803
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-03127
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- January 4, 2013
- Report Date
- January 5, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT OUT OF RANGE PACING IMPEDANCES WERE DETECTED. THERE WERE NO ADVERSE PATIENT EFFECTS. NO IMMEDIATE INFORMATION WAS AVAILABLE. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144168 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | 4469| E110| 0147 |