FDA Adverse Event Malfunction Summary report: N

VITALITY 2

MDR report key: 1871458 · Received October 15, 2010

Report

Report Number: 2124215-2010-17088
Event Type: Malfunction
Date Received: October 15, 2010
Date of Event: August 26, 2010
Report Date: August 26, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UPON RETURN TO BOSTON SCIENTIFIC CRM'S POST-MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THE DEVICE DECLARED ITS ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. ADDITIONAL LAB ANALYSIS AND TESTING SHOWED ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF DEVICE INTERNAL BATTERY IMPEDANCE. THE EOL (END OF LIFE) INDICATOR WAS NOT DECLARED WHILE THE DEVICE WAS IN SERVICE. TESTING CONFIRMED ALL DEVICE THERAPIES WERE AVAILABLE. THIS ISSUE IS DISCUSSED IN THE QUARTER 3, 2010 VERSION OF OUR PRODUCT PERFORMANCE REPORT.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THERE WERE NO KNOWN ALLEGATIONS AGAINST THE DEVICE, AND NO REPORTS OF ADVERSE PATIENT EFFECTS. THIS DEVICE IS INCLUDED IN THEMID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY POPULATION INITIALLY COMMUNICATED 3/10/2007.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VITALITY 2	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T177

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR			T177\| 0147