FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 1873866
·
Received October 19, 2010
Report
- Report Number
- 2124215-2010-17602
- Event Type
- Malfunction
- Date Received
- October 19, 2010
- Date of Event
- August 31, 2010
- Report Date
- August 31, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- PMA / PMN Number
- P010012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REQUEST A LONGEVITY COMPARISON BETWEEN RENEWAL AND COGNIS DEVICES. TECHNICAL SERVICES PROVIDED A LONGEVITY ESTIMATION AND THE LOCAL REPRESENTATIVE EXPRESSED CONCERN ABOUT THE EXPECTED LONGEVITY OF COGNIS DEVICES (AS COMPARED TO RENEWAL DEVICES) SINCE THE BATTERY CHEMISTRY HAD BEEN IMPROVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COGNIS | IMPLANTABLE CHF PULSE GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | N119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | H175| 4479| H215| 0184| 4512 |