FDA Adverse Event Malfunction Summary report: N

ALTRUA

MDR report key: 2780762 · Received October 10, 2012

Report

Report Number: 2124215-2012-13219
Event Type: Malfunction
Date Received: October 10, 2012
Date of Event: September 12, 2012
Report Date: September 19, 2012
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NVZ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED TESTS SUCH AS COMMANDED AUTO THRESHOLD AND IMPEDANCE TESTS AND THAT THE PROGRAMMER WILL TAKE THE NEW MEASUREMENT AND RECALCULATE THE LONGEVITY REMAINING. AS A COMMANDED AUTO THRESHOLD TEST WAS DONE THAT NEW THRESHOLD PLUS 0.5 V WILL BECOME THE NEW OUTPUT. IT IS ALSO POSSIBLE THAT THE DEVICE WAS RETRY DUE TO FUSION SINCE THE PATIENT HAS INTACT CONDUCTION. THE CONSULTANT PERFORMED AN ESTIMATED LONGEVITY CALCULATION WHICH WAS ABOUT 7.5 YEARS AND SEEMS TO NORMAL DEVICE OPERATION PER WHEN THE DEVICE WAS IMPLANTED. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FIVE MONTHS AGO, THIS DEVICE DISPLAYED A LONGEVITY REMAINING OF GREATER THAN FIVE YEARS. HOWEVER, TODAY IT SHOWS 3.5 YEARS LONGEVITY REMAINING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ALTRUA	IMPLANTABLE PULSE GENERATOR	NVZ	GUIDANT CRM CLONMEL IRELAND	S603

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR			4469\| S603\| 4087