Note: Although this FDA-483 is an accurate representation of the original FDA-483 issued to the firm, it is not an exact copy. Slight modifications to the original FDA-483 have been made to accommodate its conversion to the HTML format. A scanned copy of the original letter is available in PDF at the bottom of this page.
FOOD AND DRUG ADMINISTRATION
DISTRICT OFFICE ADDRESS AND PHONE NUMBER
212 3rd Ave. South
Minneapolis, MN 55401
(612) 334-4100 Fax: (612) 334-4134
DATE(S) OF INSPECTION
12/15/2005 – 02/09/2006*
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED
TO: Dale W. DeVries, Vice President of Clinicals and Regulatory Affairs
4100 Hamline Avenue North
CITY, STATE AND ZIP CODE
St. Paul, MN 55112
TYPE OF ESTABLISHMENT INSPECTED
Medical Device Manufacturer
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 WE OBSERVED:
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:
Alison A. Stone [hand amended to Alison A. Nicoli], Investigator
Ralph W. Jerndal, Investigator
SEE REVERSE OF THIS PAGE
This is a modified document
FORM FDA 483 (7/00) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS
The observations of objectional conditions and practices listed on the front of this form are reported:
Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or
To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration.