FDA Adverse Event Injury Summary report: N

VENTAK PRIZM

MDR report key: 1861065 · Received October 7, 2010

Report

Report Number: 2124215-2010-15316
Event Type: Injury
Date Received: October 7, 2010
Date of Event: July 29, 2010
Report Date: August 27, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A NEW DEVICE WAS SUCCESSFULLY IMPLANTED AND THIS DEVICE HAS NOT BEEN RETURNED. WHEN THIS DEVICE IS RETURNED FOR ANALYSIS OR SHOULD MORE INFORMATION BECOME AVAILABLE TO OUR COMPANY, A FINAL REPORT WILL BE SUBMITTED.

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.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION. THIS DEVICE IS NOT INCLUDED IN ANY ADVISORY POPULATION AND NO ADVERSE EFFECTS WERE REPORTED. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED.

Description of Event or Problem · 1

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			Required Intervention