FDA Adverse Event Malfunction Summary report: N

COGNIS

MDR report key: 3041054 · Received April 8, 2013

Report

Report Number: 2124215-2013-00686
Event Type: Malfunction
Date Received: April 8, 2013
Date of Event: November 30, 2012
Report Date: January 9, 2013
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NIK
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF DEVICE DATA BY TECHNICAL SERVICES AND ENGINEERING CONFIRMED THERE HAVE BEEN NO RESETS RECORDED IN THE DEVICE. THE DEVICE APPEARED TO BE OPERATING NORMALLY. TECHNICAL SERVICES ADVISED A THOROUGH DEVICE FOLLOW-UP POST ABLATION PROCEDURE TO ENSURE PACING OUTPUTS WERE PROGRAMMED APPROPRIATELY TO DELIVER BI-V PACING SUPPORT AS DETERMINED BY THE PHYSICIAN. AVAILABLE INFORMATION INDICATES THIS DEVICE REMAINS IN SERVICE WITH NO FURTHER ISSUES. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ABLATION PROCEDURE, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED TO OFF-ELECTROCAUTERY MODE. RIGHT VENTRICULAR (RV) PACING WAS OBSERVED, BUT NO RIGHT ATRIAL (RA) OR LEFT VENTRICULAR (LV) PACING WAS NOTED. THERE WERE NO ADVERSE PATIENT EFFECTS DUE TO THIS ISSUE. THE PHYSICIAN QUESTIONED WHETHER OFF-ELECTROCAUTERY MODE ALLOWED BI-VENTRICULAR PACING. A TECHNICAL SERVICES CONSULTANT DISCUSSED THAT BI-V PACING SHOULD BE AVAILABLE IN THAT MODE. A SAVE TO DISK WAS SUBMITTED TO TECHNICAL SERVICES FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
144013	COGNIS	IMPLANTABLE CHF PULSE GENERATOR	NIK	GUIDANT CRM CLONMEL IRELAND	P107

Patients

Seq	Age	Sex	Outcome	Treatment
1				P107