FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 1890022
·
Received November 3, 2010
Report
- Report Number
- 2124215-2010-21345
- Event Type
- Malfunction
- Date Received
- November 3, 2010
- Date of Event
- January 12, 2009
- Report Date
- September 30, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS REPROGRAMMED TO MITIGATE THE INAPPROPRIATE MODE SWITCHES. THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED NOISE ON THE RIGHT ATRIAL (RA) CHANNEL CAUSING INAPPROPRIATE MODE SWITCHES. IT WAS ALSO REPORTED THE RA PACING IMPEDANCE MEASUREMENTS WERE FLUCTUATING BETWEEN 400 AND 1,300 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
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 | 87 YR | (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4) |