FDA Adverse Event
Malfunction
Summary report: N
COGNIS
MDR report key: 1851579
·
Received October 4, 2010
Report
- Report Number
- 2124215-2010-14044
- Event Type
- Malfunction
- Date Received
- October 4, 2010
- Date of Event
- July 8, 2010
- Report Date
- July 15, 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 PHYSICIAN HAS FURTHER DECIDED TO CONTINUE TO MONITOR THIS ISSUE VIA LATITUDE.
Additional Manufacturer Narrative · 1
INFORMATION SUGGESTS THIS DEVICE AND LEAD REMAIN IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
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Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS IMPLANTED SUBPECTORAL. AN ALERT WAS NOTED VIA LATITUDE FOR A LEFT VENTRICULAR (LV) IMPEDANCE OF > 2000 OHMS. UPON TROUBLESHOOTING, IT WAS REPORTED THAT ANY CONFIGURATION THAT USED THE LV RING (ANODE) HAD AN IMPEDANCE OF >2,000 OHMS. THE DEVICE WAS PROGRAMMED LV-TIP TO RV COIL AND THE IMPEDANCE WAS NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS INCLUDED IN THE SUBPECTORAL IMPLANT ADVISORY.
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 | 75 YR | 0185| 4543| 4470| N119 |