FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2053349
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04305
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 4, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LATITUDE SYSTEM DETECTED A RED ALERT FROM THIS TRANSVENOUS DEFIBRILLATION LEAD DUE TO HIGH RIGHT VENTRICULAR (RV) IMPEDANCES. THE ALERT WAS DISCUSSED WITH THE PATIENT'S CLINIC. ADDITIONAL INFORMATION WAS PROVIDED THAT A REVISION WAS BEING DISCUSSED; HOWEVER, NOTHING HAS BEEN SCHEDULED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | 5076| E110| 0185| T165 |