FDA Adverse Event Malfunction Summary report: N

ALTRUA

MDR report key: 2913147 · Received January 14, 2013

Report

Report Number: 2124215-2012-16613
Event Type: Malfunction
Date Received: January 14, 2013
Date of Event: December 12, 2012
Report Date: December 12, 2012
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NVZ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ATRIOVENTRICULAR (AV) NODE ABLATION PROCEDURE, WHEN THE CAUTERY WAS APPLIED, APPROXIMATELY FIVE SECOND PAUSES AND PACING INHIBITION WERE OBSERVED. AN INTERNAL TECHNICAL SERVICE (TS) CONSULTANT WAS CONTACTED FOR PROGRAMMING OPTIONS TO AVOID THIS ISSUE. TS PROVIDED INFORMATION THAT THIS IS KNOWN BEHAVIOR DURING A RF ABLATION PROCEDURE AND IS DUE TO THE EXTERNAL CURRENT CAUSING SATURATION OF THE SENSE AMPLITUDE ON THE LEAD WHICH CAN RESULT IN OVERSENSING AND PACING INHIBITION. FURTHER PROGRAMMING OPTIONS WERE PROVIDED. WHEN THE ABLATING PROCESS WAS STOPPED OR STARTED, PACING WAS IMPACTED. THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE SYMPTOMS DUE TO THE PACING INHIBITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
21179	ALTRUA	IMPLANTABLE PULSE GENERATOR	NVZ	GUIDANT CRM CLONMEL IRELAND	S601

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR			4457\| S601