-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, DBRPinyj0dX9F6agIXq1NnkPJWYk3/t0xBl2nb3fogWo0wBnvkI05LvGEvKtF2ch 5HmObbC1Rafss7pks69r1g== 0000950124-07-005124.txt : 20071015 0000950124-07-005124.hdr.sgml : 20071015 20071015060231 ACCESSION NUMBER: 0000950124-07-005124 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20071015 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071015 DATE AS OF CHANGE: 20071015 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDTRONIC INC CENTRAL INDEX KEY: 0000064670 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 410793183 STATE OF INCORPORATION: MN FISCAL YEAR END: 0430 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-07707 FILM NUMBER: 071170879 BUSINESS ADDRESS: STREET 1: 710 MEDTRONIC PKWY STREET 2: MS LC300 CITY: MINNEAPOLIS STATE: MN ZIP: 55432 BUSINESS PHONE: 7635144000 MAIL ADDRESS: STREET 1: 710 MEDTRONIC PKWY CITY: MINNEAPOLIS STATE: MN ZIP: 55432 8-K 1 c19341e8vk.htm CURRENT REPORT e8vk
Table of Contents

 
 
UNITES STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 15, 2007
Medtronic, Inc.
(Exact name of Registrant as Specified in its Charter)
         
Minnesota   1-7707   41-0793183
         
(State or other jurisdiction of incorporation)   (Commission File Number)   (IRS Employer Identification No.)
         
710 Medtronic Parkway Minneapolis, Minnesota
  55432
     
(Address of principal executive offices)
  (Zip Code)
         
(Registrant’s telephone number, including area code): (763) 514-4000
         
Not Applicable
 
(Former Name or Former Address, if Changed Since Last Report)
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:
    o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
    o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
    o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
    o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


TABLE OF CONTENTS

Item 7.01. Regulation FD Disclosure.
Item 9.01. Financial Statements and Exhibits.
SIGNATURES
EXHIBIT INDEX
Press Release


Table of Contents

Item 7.01. Regulation FD Disclosure.
On October 15, 2007, Medtronic, Inc. issued the press release furnished herewith as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. Exhibit 99.1 Press release dated October 15, 2007.
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.
         
    MEDTRONIC, INC.
 
 
 
Date: October 15, 2007   By   /s/ Terrance L. Carlson
        Terrance L. Carlson
Senior Vice President, General Counsel and Corporate Secretary
 
 

 


Table of Contents

EXHIBIT INDEX
Medtronic, Inc.
Form 8-K Current Report
     
Exhibit Number   Description
99.1
  Press release dated October 15, 2007

 

EX-99.1 2 c19341exv99w1.htm PRESS RELEASE exv99w1
 

Exhibit 99.1
     
(MEDTRONIC LOGO)   NEWS RELEASE
         
 
  Contacts:   Rob Clark
 
      Medtronic Media Relations
 
      763-505-2635
 
       
 
      Martha Goldberg Aronson
 
      Medtronic Investor Relations
 
      763-505-2694
FOR IMMEDIATE RELEASE
MEDTRONIC VOLUNTARILY SUSPENDS DISTRIBUTION
OF SPRINT FIDELIS
® DEFIBRILLATION LEADS
Physician Experts Advise Against Prophylactic Replacement of Implanted Leads
MINNEAPOLIS – October 15, 2007 – Medtronic, Inc. (NYSE:MDT) said today that it has voluntarily suspended worldwide distribution of the Sprint Fidelis® family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949).
The Sprint Fidelis leads are used to deliver therapy in defibrillators only, including Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy – Defibrillators (CRT-Ds). Approximately 268,000 Sprint Fidelis leads have been implanted worldwide. This action does not affect Medtronic pacemaker patients.
The U.S. Food and Drug Administration (FDA) intends to issue a public statement regarding Medtronic’s decision at www.fda.gov.
Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of Medicine, Director of Cardiac Electrophysiology, Washington University School of Medicine and President of the Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. Medtronic has provided patient management recommendations that should reduce risks in the affected population and recommends that patients with questions consult their physicians. Information is also available for patients and physicians at www.medtronic.com/fidelis.

 


 

This decision is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action. Based on Medtronic’s extensive performance data, Sprint Fidelis lead viability is trending lower than Medtronic’s Sprint Quattro® lead at 30 months (97.7% Sprint Fidelis vs. 99.1% Sprint Quattro). This difference is not statistically significant; however, if the current lead fracture rates remain constant, it will become so over time. Medtronic believes that given this performance trend and its ability to identify the primary fracture locations, this action is in patients’ best interest.
Lead fractures may present clinically as audible alerts, inappropriate shocks and/or loss of output. Based on current information regarding the 268,000 implanted leads, Medtronic has identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.
“There is nothing more important to us than the safety and well-being of patients,” said Bill Hawkins, president and chief executive officer of Medtronic. “We take all matters of product quality very seriously and believe this action is the right thing to do given currently available information.”
Medtronic Outreach to Physicians and Patients
In conjunction with Medtronic’s Independent Physician Quality Panel, Medtronic today communicated, via letter and direct outreach with more than 13,000 physicians worldwide, the Sprint Fidelis lead performance data and updated patient management recommendations for patients who are implanted with Sprint Fidelis leads. These recommendations include device programming and patient management recommendations that will ensure a patient’s device is set to more effectively monitor for potential problems and provide an audible alert in the event of lead fractures.
“Medtronic has acted responsibly to address concerns about the possibility of lead fractures and to minimize harm to patients,” said Kevin Hackett, M.D. of Columbus Cardiology Consultants and member of Medtronic’s Independent Physician Quality Panel. “The Physician Panel has reviewed Medtronic’s data and believes they are taking the correct action.”
Information for Patients
Medtronic recommends that patients, who believe they may have a Fidelis lead, consult with their physicians. It is important to note that Medtronic pacemaker patients are not affected by this action. Medtronic will communicate directly to affected patients and encourage them to contact their physicians

 


 

for more information. Medtronic has established the following website – www.medtronic.com/fidelis – and a toll-free number (1-800-551-5544 ext. 41835) for patients seeking information.
Investor Conference Call/Webcast
Medtronic will host an investor webcast later this morning at 8:15 a.m. eastern time / 7:15 a.m. central time. To listen to the live audio webcast or a replay of the webcast, please refer to the Investor Relations webpage at http://investorrelations.medtronic.com/.
Media Briefing
Medtronic will host a media briefing at 11 a.m. eastern time / 10 a.m. central time. Media may access this briefing by dialing 1-888-550-2358. Medtronic representatives and expert physicians will be available on this call.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any statements made about the anticipated regulatory review or approval are forward-looking statements and subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 27. 2007.  Actual results may differ materially from anticipated results.
- end -

 

GRAPHIC 3 c19341c1934101.gif GRAPHIC begin 644 c19341c1934101.gif M1TE&.#EA&`$Y`,00`(FSS<79YO'V^2)QH&R@P#^$K:?&V>+M\WNJQC%ZI]3C M[+;0X%V7NIB]TTZ-LQ-GFO___P`````````````````````````````````` M`````````````````````````"'Y!`$``!``+``````8`3D```7_("2.9&F* M`>$@Q^F^<"S/=&W?>*[O?)\OC^!CH/`9C\BD8.KD,P#U]O76(P?W]_G1^_SJ::NTJ]>(`&#>D5#VH`"!(`-=?/,W M+X88320"7'R`3)K&BP!4U7H`H(7&3`4`_RQHQ)"DE!D'!@PX5R,@OUD0;-ZC MV61C1Q0^IWT4$U(5G0<*!7#3M$_(FR`X70#Y24/1QB!F]%T-0K'G1:I#PU`% M%C9*44M`&!C(Y$]!@+5#&#@5$O&%W*[-MB(EP>[J62=!#P:.5M:IJE`M%(V" ML`"`P09A6F:5H8A9#,AWA>[])[## M.30L=54XF.F%D_\"!/`610&W0="`@QRA$E1+VR%SG6&)$)")91U2N`P+)8B& MC`"<"4'`+`HXX.*++G:U#QB]Q:>$*P:A,T1_0S1@56[ZT8`C#=L-(8))WXB1@"?!G<5EE>PA\=!](K@R M0(X+9,*9`]Q(-]T#HQC@@&E$^8VQ'Q29538JB7AB!I%P6A1:IC M8I=A5!=::2)`JE>:1X`!`)L*(.E`(S$M0\<`"#!GHPFA0(`'>U)NA4N5(6FJ MUY@2(IHHHHR*`8D8-.JJD&B!1@D42%L&6R2G/'!IH`-%**#L*Z@(@&3_`5=" M&!4)=S7T0(2*7G5+E:-0&D6Q(1FH*S+A]J;:1<7J2M>E\NI7)I6Z,KL#&`,X M0```4##`4$H+!+``'=;,28<#!3=PE"%LBJ`,')#1=B2B2&9H%;`FB4C,1@PT M%B\RZJ4HECW67+FNR"#3*V]'98YT%:H+?)=-3U3E%\0`>#GS0((N"O%FI@8P MP$T"*^`30&X.:&0Q!-.Z5J2Z0B081BY`B'&E9U9/*1BR)*A!%L3,Y[<)&"9@+K,E19%L"HI/I M_%5&F(:]%"O(?AHDL.DHG!>UWF[99J\6T.,AL"T;&C MBP"9<<$AX/A5"]!>+Z(E^`XYV,F'P:?*`R'N%/(B7-DY4;?;"=@`"PAP\!BQ M7V-`YJES='.;:?L4*;QCCUT8YW,AB5H8!."G[UUE%N+[&E'"!Z_>;60@*@,` M^]ZEM6/!SUU<4)\F&C<>**4#"`.)%1D0H#MXN4"$Q2->$#2S/01U%Q,4,8CR@;=Y\'(W&X`:$@!'%`AK=X8X#L-@@0+'Q`[5Q3`"TOIES+& M5+-5J:P(WHN,"'0E#_\77"DU?FI>&$=3/@Z-X'/JJ&$4YO,X'HJIB&9IH.6V M\)!SI$!W+E()3NB$`(?D818/L9AB9%"L3&VE&&*[2,3T\9T+)D*!0AB4V"QW M)=,X2@R].``FD3C$C?0B9EXZQR.JMP-71.@%`4,``A+`C15E2B8G<&4,Y-@- M$6"2.W840Z!XE@L&-D`NT+*A%`!`M<=UDE4.A$8IZQ42&)XK6*S407[D9\8H M:.\I`QC>`R(FEVV-KX,B(-Y/X%@O9#0S#+OC%0?%6*+OS<1EB7OC]T)2*D1E M4P?(&5`4)O,0@R@C(HN,0:R$D)HU_DR?(,G8V!BC%R(H,VWS-,L)9(@=/++_ M<6.Z*LI"'XF%=-@@14@<06N*K* M'QO$5TC7$4_072$3JTJ&BA:W&(WXL#(S0!\)HI92$7SR01(KZA#\`<<1<+0A M!OAEK^AY@M@L:B!!9A&Y8T2#(X2E=HN3D0O2M_&\W=B^[CL-SY4#5Z M=1$MBL8Y!.0O5`^*70`D.D,$Y*(!TW((*EBHUU>*X&_`84)3$K1D.#MGA6)KG1]X`IO>[.-C% M:V"`S1.TYIY02`AXU\O>&/@'M5'H+620P8XRMO>^]TT=>X(%`[F@`@P.L,=J M\4M@Z6)&>R;(&`PT,HHES3$'!F,@7@N,G_F00`&634)M-=P]W/++`+,8F`L. MP)FJ;JF0SYM!G(3QI@,D8,`CP`4,,%R#.;@H?P7#[8M(I(,T9+@H1S[:TB9,'`-PEN&R[EANB<%P@-'.,LLPZ9=5'R"( M!^B683!H0))?0,5:Q$XM-)!E3F;;WPR3H`$@6D`XIT-E`L`8*%5H#`_PY@B[ MRB#%(F`$!&[!&"7CV35((O_`?-S3PC'H`0C!2H`DK"/8G&BF:-!K,@R`4(4` M[\L,0'C!IHT@L!'4+`S,N4'K.@*A15O##>]0,P0(8+:D%,U'*E``EP1AV!2TP`"VLQP!1M$:`R@` M`$UBD".H;0!;FN#7V("&`*3MA0-P@@KG/NTA6/`("95$TG/[EY**MZ4$6&-I M19CW%*!F;G_9FP$'0$"$7@P!QW(I$8Z]G@`B7A+'+@#!$C*:&1HP\D\!W`OU MV`R?O(/%DGB!!V8UK863X.+%(@/>9E8*:@HP"I(D0#,',.TX7?$OI#:(`1Y: M&H3_FKTY]Q2@`<=DP!4+P`RY"(S,*+@S1S2]<9Y1D0#%#J2>6T.G`A1@EDMW MD/F`4C7W(.S`RPDH`;U%PPN2A`SP^#8Z!XS M"%WQF^/)&8I@D#PTLH>#0:T7IJ4HU!<#A!Q!:"U',OL3+9,`,W!]G(9H7R\* M$$YBL##VFTD-`"#.$8@G0`''-,8H%D!#Y_SK8HB`K,2RFH_B0^#GQ?\[)J;] M&K!GR9=CHM\XD7YA,]/BGF:>"I]P4!:((8%N[1,2:G$`_VI1;F/&)V!SBG`(J0%3%A'T3@"J50 M?%C7&EU&1"`9P$V(:/R=-O4(B`W`IH&0,SD$%_@`+6@`'HV M*B:`;D*H$20V']!22`SS&L7W:M,62!HB%I"(.OQQ%>,`K8XC"R4`)[F!/,E#3OL`DD MEPIZ`BVMMP*:5CJGY2)%L!;YD!+QA@G6T&Q;6`3(("UF@"H0A(R,L0G39RTK MHF['%#'!:`T'HR<,((A[B'0"\"30V`AD8"TM<':,00Q\X2+O<#`Q4CA0XUA7 MA`FX8'YCLHW+Y5>OAA#
-----END PRIVACY-ENHANCED MESSAGE-----