FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 3052755
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05216
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- February 28, 2013
- Report Date
- March 31, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- PMA / PMN Number
- P010012
- 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.
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THROUGH A REMOTE MONITORING SYSTEM THAT DETECTED AN OUT OF RANGE HIGH PACING IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS NO INFORMATION IMMEDIATELY AVAILABLE. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED THAT THIS LEAD HAS AND WILL CONTINUE TO BE MONITORED WITH NO PLANNED INTERVENTION. NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154899 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | 4555| 4135| 4543| N119| 0175 |