This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above.

The observations noted in this Form FDA-483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self-audits to identify and correct any and all violations of the quality system requirements.

DURING AN INSPECTION OF YOUR FIRM WEOBSERVED:

OBSERVATION 1

Not all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems have been identified.

Specifically, an analog to digital latching fault has been identified in Prizm I, Prizm II and Vitality pulse generators that can result in a loss of tachy therapy. There have been four confirmed and two unconfirmed field events since 5/13/2002 for this cause. A software fix was developed by 5/6/2004 (SCR #1883) to correct this fault in the Renewal RF design project. However, a fix was not submitted to FDA for certain affected preexisting devices until August, 2005.

Annotation: Promised to correct.

* DATES OF INSPECTION

12/15/2005(Thu), 12/19/2005(Mon), 12/20/2005(Tue), 12/21/2005(Wed), 12/22/2005(Thu), 01/03/2006(Tue), 01/04/2006(Wed), 01/05/2006(Thu), 01/06/2006(Fri), 01/10/2006(Tue), 01/11/2006(Wed), 01/13/2006(Fri), 01/17/2006(Tue), 01/18/2006(Wed), 01/25/2006(Wed), 01/26/2006(Thu), 01/27/2006(Fri), 01/30/2006(Mon), 01/31/2006(Tue), 02/01/2006(Wed), 02/09/2006(Thu)

FDA EMPLOYEE'S NAME, TITLE, AND SIGNATURE:

[Handwritten Signature]

Alison A. Stone [hand amended to Alison A. Nicoli], Investigator

[Handwritten Signature]

Ralph W. Jerndal, Investigator

This is a modified document

The observations of objectional conditions and practices listed on the front of this form are reported:

1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or
2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration.

“Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgement, indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary.”