FDA Adverse Event Malfunction Summary report: N

ALTRUA

MDR report key: 1853599 · Received October 5, 2010

Report

Report Number: 2124215-2010-14968
Event Type: Malfunction
Date Received: October 5, 2010
Date of Event: July 19, 2010
Report Date: July 19, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NVZ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AT THIS TIME, THIS PRODUCT REMAINS IMPLANTED; HOWEVER, DURING THE REPLACEMENT PROCEDURE, IT WILL BE REEVALUATED. IF IT IS EXPLANTED AND RETURNED FOR ANALYSIS, OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FINAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM THE CLINIC TECHNICIAN THAT THIS PACEMAKER HAS A LONGEVITY STATUS OF LESS THAN TWO YEARS REMAINING. THE CURRENT PROGRAMMING IS 100% VENTRICULAR PACING AT 5.0V@ 1.0MS. IT WAS REPORTED THAT WHEN THE DEVICE TRIGGERS ELECTIVE REPLACEMENT TIME, A REPLACEMENT PROCEDURE WILL BE SCHEDULED, AND THE DEVICE WILL BE EXPLANTED AND RETURNED FOR ANALYSIS AT THAT TIME. THIS DEVICE IS NOT INCLUDED IN ANY ADVISORY POPULATION AND IT HAS BEEN IMPLANTED FOR APPROXIMATELY 10 MONTHS. NO ADVERSE EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ALTRUA	IMPLANTABLE PULSE GENERATOR	NVZ	GUIDANT CRM CLONMEL IRELAND	S203

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening