FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3053217
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05636
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- March 12, 2013
- Report Date
- April 4, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE CLINIC WAS GOING TO CONTINUE TO FOLLOW THIS PATIENT AND THE IMPEDANCE TRENDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT THIS PATIENT'S HOME MONITORING SYSTEM TRANSMITTED THAT A LOW, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM HAD BEEN DETECTED. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FIELD REPRESENTATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155325 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | E102| 0185 |