FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2051818
·
Received April 12, 2011
Report
- Report Number
- 2124215-2011-03718
- Event Type
- Injury
- Date Received
- April 12, 2011
- Date of Event
- February 14, 2011
- Report Date
- June 30, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN THIS LEAD HAS BEEN RETURNED, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT NO RETURN OF PRODUCT IS INTENDED. WITHOUT A RETURN OF PRODUCT, THIS CLINICAL OBSERVATION CANNOT BE CONFIRMED NOR DENIED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS GENERATED DUE TO THIS RIGHT VENTRICULAR HIGH DISPLAYING HIGH OUT OF RANGE PACE AND SHOCK IMPEDANCE MEASUREMENTS. THE DEVICE VENTRICULAR TACHY MODE WAS PROGRAMMED TO VALUE OTHER THAN MONITOR + THERAPY MODE. A REVISION PROCEDURE WAS PERFORMED, THIS LEAD WAS REMOVED AND REPLACED. 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 | Other| R |