SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January
ST. JUDE MEDICAL, INC.
(Exact name of registrant as specified in its charter)
or other jurisdiction
|One St. Jude Medical Drive, St. Paul, MN
|(Address of principal executive offices)
Registrant’s telephone number, including area
code: (651) 756-2000
(Former name or former address, if changed since last
Check the appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following provisions:
||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Item 8.01 Other Events.
On January 11, 2013, St. Jude Medical,
Inc.’s (the “Company”) Implantable Electronic Systems Division
(formerly known as its Cardiac Rhythm Management Division) received a warning letter dated January 10, 2013 from the U.S. Food
and Drug Administration (the “FDA”) related to observed non-conformities with Current Good Manufacturing Practice at
the Company’s Implantable Electronic Systems Division’s Sylmar, California facility. This warning letter is specific
to the Company’s Sylmar, California facility and does not impact any of the Company’s other manufacturing facilities.
As previously disclosed by management on its third quarter earnings call on October 17, 2012, this warning letter was expected.
The FDA inspected the Company’s Sylmar, California manufacturing facility
from September 25 to October 17, 2012. On October 17, 2012, the FDA issued a Form 483 (the “Form 483”) identifying
certain observed non-conformities with Current Good Manufacturing Practice. Following the receipt of the Form 483, the Company’s
Implantable Electronic Systems Division provided written responses to the FDA detailing proposed corrective actions and immediately
initiated efforts to address FDA’s observations of non-conformity. The warning letter relates to the observations reflected
in the Form 483.
The FDA letter notes that it will not grant requests for exportation certificates
to foreign governments or approve pre-market approval applications for Class III devices to which the quality system regulation
deviations are reasonably related until the violations have been corrected. The warning letter does not, however, identify
any specific concerns regarding the performance of, or indicate the need for any field or other action regarding, the Riata ST
Optim or Durata leads or any other St. Jude Medical product. Accordingly, the Company will continue manufacturing and shipping
product from the Sylmar facility and customer orders are not expected to be impacted while we work to resolve the FDA’s concerns.
The Company takes this matter seriously and has already begun to respond to the
FDA’s requests. The Company is giving the highest priority to fully remediating these concerns.
Consistent with the Company’s prior disclosures on this matter, the Company
has taken the appropriate regulatory circumstances into account in managing its business and setting investor expectations, and
believes the FDA’s concerns can be resolved without a material impact on the Company’s financial results. The
Company will provide financial guidance for 2013 which will incorporate any impact from this warning letter on its fourth quarter
earnings call scheduled for January 23, 2013.
Pursuant to the requirements of the Securities Exchange
Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ST. JUDE MEDICAL, INC.
|Date: January 14, 2013
||/s/ Jason Zellers|
Vice President, General Counsel
and Corporate Secretary