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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND
EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) November 19, 1999
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MINIMED INC.
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(Exact Name of Registrant as Specified in its Charter)
Delaware 0-26268 95-4408171
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(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
12744 San Fernando Road, Sylmar, California 91342
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (818) 362-5958
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N/A
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(Former Name or Former Address, if Changed Since Last Report)
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ITEM 5. OTHER EVENTS.
On November 19, 1999, MiniMed Inc. announced a patient notification
relating to its Model 508 insulin infusion pump. The press release filed as an
exhibit hereto, and incorporated by reference herein, provides additional
details regarding the patient notification.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
The Exhibits to this report are listed in the Index to Exhibits on
page 3.
SIGNATURES
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.
Date: November 19, 1999 MINIMED INC.
By: /s/ Eric S Kentor
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Name: Eric S. Kentor
Its: Senior Vice President, General Counsel and
Secretary
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INDEX TO EXHIBITS
Exhibit No. Description
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99.1 Press release dated November 19, 1999
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NEWS RELEASE For: MiniMed Inc.
Contact: Terrance H. Gregg
President and Chief Operating Officer
Kevin R. Sayer
Senior Vice President and
Chief Financial Officer
818-362-5958
FOR IMMEDIATE RELEASE Investor Relations
Robert P. Jones/Ephraim R. Bernstein
(212) 850-5600
Media: Sheryl Seapy
415-296-7383
Morgen-Walke Associates
MINIMED INC. ANNOUNCES PATIENT NOTIFICATION
Sylmar, California, November 19, 1999 -- MiniMed Inc. (Nasdaq: MNMD)
announced today that it is initiating a patient notification procedure relating
to a rare and minor software error which could occur in certain of its Model 508
insulin infusion pumps distributed since October 1999. MiniMed reported that
this situation may be created by a very specific programming sequence that some
users may possibly follow. The company stated that the issue has been addressed,
and all products shipped beginning today contain an upgraded version of the
software.
Alfred E. Mann, MiniMed's Chairman and CEO, stated, "This situation was
identified quickly as a result of the strict performance monitoring which we
conduct on all of our products. A notification containing programming
instructions which will eliminate this potential occurrence has been sent to
those pump users who purchased Model 508 pumps from October 4 through November
18. We believe that the MiniMed 508 offers the state of the art in safety,
reliability and clinical benefit for patients who treat their diabetes with
continuous insulin infusion."
Terrance H. Gregg, MiniMed's President and Chief Operating Officer,
added, "Our independent medical monitor confirmed for us that this anomaly does
not represent an urgent matter. In addition to the patient notification, we will
upgrade the software in the affected pumps early next year. Our estimated cost
for this activity is expected to range between $1 million and $1.5 million."
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MiniMed Inc. designs, develops, manufactures and markets advanced
infusion systems with a primary emphasis on the intensive management of
diabetes. The Company's products include external pumps and related disposables,
a continuous glucose monitoring system product and the distribution of an
implantable insulin pump, which is currently approved for sale in the European
Community and has not yet been cleared for marketing in the U.S. The Company
also distributes other diabetes supplies and pharmaceutical products.
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Any statements made by MiniMed in this press release that are
forward-looking, including statements relating to the costs associated with
upgrading the software in affected pumps, are made pursuant to the Safe Harbor
provisions of the Private Securities Reform Act of 1995. Investors are cautioned
that forward-looking statements involve risks and uncertainties which may affect
MiniMed's business and prospects, including changes in economic and market
conditions, the number of MiniMed employees or outside consultants available to
upgrade the affected pumps, administration and regulatory approval and related
considerations and other factors discussed in the Company's filings with the
Securities and Exchange Commission.
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