VITALITY 2

MDR report key: 1954207 · Received January 10, 2011

Report

Report Number: 2124215-2011-00194
Event Type: Injury
Date Received: January 10, 2011
Date of Event: December 13, 2010
Report Date: January 25, 2011
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

Additional Manufacturer Narrative · 1

A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

Additional Manufacturer Narrative · 1

NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LONGER THAN NORMAL CHARGE TIME MEASUREMENTS WERE NOTED AND THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI). A DEVICE REPLACEMENT PROCEDURE WAS PERFORMED ONE WEEK LATER. THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION HOWEVER IT WAS REPORTED THAT THE BATTERY LASTED LESS THAN FOUR YEARS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VITALITY 2	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T175

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Life Threatening\| R	0185\| T175