VENTAK PRIZM

Report

Report Number: 2124215-2010-15938
Event Type: Injury
Date Received: October 5, 2010
Date of Event: July 19, 2010
Report Date: July 19, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: HI
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ERI AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE ERI CHARGE TIME LIMIT OF 18 SECONDS. THE DEVICE PASSED A SERIES OF DIAGNOSTIC TESTS TO ASSESS THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING, HIGH VOLTAGE SHOCKING, AND DIAGNOSTIC RECORDING FUNCTIONS. THE DEVICE'S MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE AND PROGRAMMED SETTINGS. CHARGE TIMES IN EXCESS OF THE 18 SECOND ERI CHARGE TIME LIMIT TRIGGERED ERI EARLIER THAN EXPECTED. THIS WAS DUE TO A BUILD-UP OF INTERNAL BATTERY IMPEDANCE, PREVENTING THE DEVICE FROM MEETING ITS EXPECTED LONGEVITY PER DEVICE LABELING. THIS ISSUE IS DISCUSSED IN OUR Q2 2010 CRM PRODUCT PERFORMANCE REPORT. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER APPROXIMATELY 54 MONTHS OF IMPLANT, WITH A BATTERY MONITORING VOLTAGE OF 2.71 V, AND A CHARGE TIME OF 19.5 SECONDS. THE DEVICE WAS SUCCESSFULLY REPLACED WITH ANOTHER BOSTON SCIENTIFIC DEVICE, AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED IN THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VENTAK PRIZM	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	1852

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Required Intervention	E102\| 1857\| 1852\| 1749\| 1555\| 0158\| 0074