FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 2053287
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-03892
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 2, 2011
- Report Date
- March 2, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE REMAIN IMPLANTED AND THUS WILL NOT BE RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE SHOCKING IMPEDANCES. REPROGRAMMING OF THIS CARDIAC RESYCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TOOK PLACE TO MITIGATE THIS ISSUE, AND SHOCKING IMPEDANCES HAD NORMALIZED AND REMAINED WITHIN NORMAL RANGE. 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 | N107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |