FDA Adverse Event Malfunction Summary report: N

INSIGNIA

MDR report key: 1771628 · Received July 27, 2010

Report

Report Number: 2124215-2010-13675
Event Type: Malfunction
Date Received: July 27, 2010
Date of Event: February 5, 2008
Report Date: June 7, 2010
Manufacturer: GUIDANT CLONMEL IRELAND
Product Code: NVZ
Removal / Correction Number: Z-0187-06 THRU Z-0190-06
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CRM CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT INITIAL INTERROGATION OF THIS PACEMAKER SHOWED LESS THAN SIX MONTHS TO ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS NOTED THAT THIS PATIENT WAS EXPERIENCING INTERMITTENT ATRIAL TACHYCARDIA (AT) AND THE DEVICE WAS UNDERSENSING SOME OF THIS DUE TO A KNOWN ISSUE WITH THE ASSOCIATED ATRIAL LEAD. ATRIAL LEAD IMPEDENCE HAD DECREASED TO 200 OHMS FROM 600 OHMS. ATRIAL SENSITIVITY WAS THEN REPROGRAMMED FROM .75MV TO 0.5MV TO TRY AND SENSE SOME OF THE AT. HOWEVER, THEN THE BATTERY STATUS CHANGED FROM LESS THAN SIX MONTHS REMAINING TO 1.5 YEARS REMAINING. THIS DEVICE IS INCLUDED IN THE INSIGNIA MICROCRYSTAL FAILURE MODE 2 POPULATION ((B) (6)2005). TWO YEARS LATER, THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INSIGNIA	IMPLANTABLE PULSE GENERATOR	NVZ	GUIDANT CLONMEL IRELAND	1298

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR			4063\| 1298\| 4035