FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 2050733
·
Received April 12, 2011
Report
- Report Number
- 2124215-2011-04091
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- February 18, 2011
- Report Date
- February 18, 2011
- 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
AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND AT THIS TIME, OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION VIA A LATITUDE RED ALERT THAT THIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR AND THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH, OUT OF RANGE PACING IMPEDANCES. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE. AS OF TODAY OUR RECORDS INDICATE THAT THE DEVICE REMAINS IN SERVICE. 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 | 80 YR | 0158| H170| 4538| 4470| N119 |