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U.S. Department of Health and Human Services

Class 2 Device Recall Maximo II CRTD

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 Class 2 Recall
Maximo II CRTD
see related information
Date Posted October 21, 2010
Recall Status1 Terminated on March 15, 2012
Recall Number Z-0112-2011
Recall Event ID 55922
Premarket Approval
PMA Number
P010031/S084
Product Classification Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
Product Medtronic Maximo II CRT-D, model D284TRK. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (VVE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA. The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, and ventricular tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF). Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device responds to bradyarrhythmias by providing bradycardia pacing therapies.
Code Information Model D284TRK, serial numbers: PZP200002H thru PZP200023H, PZP200025H thru PZP200084H, PZP200086H thru PZP200132H, PZP200134H thru PZP200228H, PZP200230H thru PZP200266H, PZP200268H, PZP200271H, PZP200272H, PZP200273H, PZP200275H thru PZP200361H, PZP200363H, PZP200364H, PZP200365H, PZP200366H, PZP200367H, PZP200369H thru PZP200442H, PZP200444H thru PZP200533H, PZP200535H thru PZP200602H, PZP200604H, PZP200605H, PZP200606H, PZP200607H, PZP200608H, PZP200609H, PZP200611H, PZP200613H thru PZP200770H, PZP200772H thru PZP200782H, PZP200784H, PZP200785H, PZP200787H, PZP200788H, PZP200789H, PZP200790H, PZP200791H, PZP200792H, PZP200793H, PZP200794H, PZP200795H, PZP200797H thru PZP200830H, PZP200832H thru PZP201059H, PZP201061H, PZP201062H, PZP201063H, PZP201064H, PZP201065H, PZP201066H, PZP201067H, PZP201068H, PZP201070H thru PZP201089H, PZP201091H thru PZP201209H, PZP201211H thru PZP201300H, PZP201302H thru PZP201341H, PZP201343H thru PZP201385H, PZP201387H thru PZP201422H, PZP201424H thru PZP201442H, PZP201444H, PZP201445H, PZP201446H, PZP201447H, PZP201449H thru PZP201471H, PZP201473H thru PZP201519H, PZP201521H thru PZP201633H, PZP201635H, PZP201636H, PZP201637H, PZP201639H, PZP201640H, PZP201641H, PZP201642H, PZP201643H, PZP201644H, PZP201645H, PZP201646H, PZP201647H, PZP201648H, PZP201649H, PZP201650H, PZP201651H, PZP201652H, PZP201653H, PZP201654H, PZP201655H, PZP201657H thru PZP201685H, PZP201687H, PZP201688H, PZP201690H, PZP201692H thru PZP201846H, PZP201848H thru PZP201903H, PZP201905H thru PZP202071H, PZP202073H thru PZP202136H, PZP202138H thru PZP202211H, PZP202213H thru PZP202244H, PZP202246H, PZP202247H, PZP202248H, PZP202249H, PZP202250H, PZP202251H, PZP202252H, PZP202253H, PZP202254H, PZP202255H, PZP202257H, PZP202258H, PZP202259H, PZP202260H, PZP202261H, PZP202262H, PZP202263H, PZP202265H, PZP202266H, PZP202268H, PZP202269H, PZP202270H, PZP202271H, PZP202272H, PZP202273H, PZP202274H, PZP202275H, PZP202276H, PZP202278H, PZP202279H, PZP202280H, PZP202281H, PZP202282H, PZP202283H, PZP202284H, PZP202285H, PZP202286H, PZP202287H, PZP202288H, PZP202291H, PZP202292H, PZP202293H, PZP202294H, PZP202295H, PZP202296H, PZP202297H, PZP202299H thru PZP202315H, PZP202317H thru PZP202402H, PZP202404H thru PZP202495H, PZP202497H thru PZP202635H, PZP202637H thru PZP202699H, PZP202701H thru PZP202743H, PZP202745H thru PZP202756H, PZP202758H, PZP202759H thru PZP202953H, PZP202955H, thru PZP203089H, PZP203091H thru PZP203151H, PZP203153H, PZP203154H, PZP203155H, PZP203156H, PZP203158H thru PZP203203H, PZP203205H thru PZP203257H, PZP203259H thru PZP203286H, PZP203288H, PZP203289H, PZP203290H, PZP203291H, PZP203292H, PZP203294H, PZP203297H thru PZP203329H, PZP203331H, PZP203332H, PZP203334H, PZP203335H, PZP203336H, PZP203337H, PZP203338H, PZP203339H, PZP203340H, PZP203342H, PZP203343H, PZP203344H, PZP203345H, PZP203346H, PZP203347H, PZP203348H, PZP203349H, PZP203350H, PZP203351H, PZP203352H, PZP203353H, PZP203354H, PZP203355H, PZP203356H, PZP203357H, PZP203358H, PZP203360H, thru PZP203433H, PZP203435H thru PZP203459H, PZP203461H thru PZP203507H, PZP203509H thru PZP203526H, PZP203528H thru PZP203754H, PZP203756H, PZP203757H, PZP203758H, PZP203759H, PZP203760H, PZP203761H, PZP203762H, PZP203763H, PZP203764H, PZP203765H, PZP203766H, PZP203767H, PZP203768H, PZP203770H thru PZP203847H, PZP203849H thru PZP204116H, PZP204118H thru PZP204160H, PZP204162H thru PZP204260H, PZP204262H thru PZP204276H, PZP204278H thru PZP204519H, PZP204521H thru PZP204585H, PZP204587H, PZP204588H thru PZP204618H, PZP204620H thru PZP204711H, PZP204713H thru PZP204883H, PZP204885H thru PZP204940H, PZP204942H, PZP204943H, PZP204946H, PZP204948H thru PZP205027H, PZP205029H thru PZP205111H, PZP205113H thru PZP205122H, PZP205124H, PZP205125H, PZP205126H, PZP205127H, PZP205129H thru PZP205213H, PZP205215H thru PZP205255H, PZP205257H thru PZP205328H, PZP205330H thru PZP205391H, PZP205393H thru PZP205447H, PZP205449H thru PZP205903H, PZP205905H thru PZP206021H, PZP206023H thru PZP206078H, PZP206080H, thru PZP206108H, PZP206110H, thru PZP206161H, PZP206163H thru PZP206193H, PZP206195H thru PZP206245H, PZP206249H, PZP206251H thru PZP206354H, PZP206356H thru PZP206430H, PZP206432H thru PZP206618H, PZP206620H thru PZP206663H, PZP206665H thru PZP206713H, PZP206716H PZP206859H thru PZP207074H, PZP207076H thru PZP207093H, PZP207095H thru PZP207147H, PZP207149H thru PZP207214H, PZP207216H thru PZP207255H, PZP207257H thru PZP207284H, PZP207286H thru PZP207381H, PZP207383H thru PZP207405H, PZP207407H, PZP207409H, PZP207410H, PZP207411H, PZP207412H, PZP207413H, PZP207415H thru PZP207621H, PZP207623H thru PZP207674H, PZP207676H thru PZP207823H, PZP207826H thru PZP208195H, PZP208197H, PZP208198H thru PZP208218H, PZP208220H thru PZP208362H, PZP208364H thru PZP208420H, PZP208422H, PZP208424H thru PZP208465H, PZP208467H thru PZP208878H, PZP208880H thru PZP208921H, PZP208923H thru PZP208970H, PZP208972H thru PZP209136H, PZP209138H thru PZP209219H, PZP209221H thru PZP209257H, PZP209259H thru PZP209585H, PZP209588H thru PZP209730H, PZP209732H thru PZP209750H, PZP209752H thru PZP209768H, PZP209770H thru PZP209804H, PZP209807H thru PZP209886H, PZP209888H, PZP209891H thru PZP209933H, PZP209935H thru PZP209977H, PZP209979H thru PZP210069H, PZP600001S, PZP600002S, PZP600003S, PZP600004S, PZP600005S, PZP600006S, PZP600087S thru PZP600180S, PZP600182S, PZP600183S, PZP600184S, PZP600185S, PZP600186S, PZP600187S, PZP600188S, PZP600190S, PZP600191S, PZP600192S, PZP600193S, PZP600194S, PZP600195S, PZP600196S, PZP600197S, PZP600198S, PZP600199S, PZP600200S, PZP600202S thru PZP600219S, PZP600221S thru PZP600278S, PZP600280S, PZP600281S, PZP600282S, PZP600283S, PZP600284S, PZP600285S, PZP600286S, PZP600287S, PZP600289S, PZP600291S, PZP600292S, PZP600293S, PZP600295S thru PZP600313S, PZP600318S, PZP600319S, PZP600320S, PZP600323S, PZP600324S, PZP600325S, PZP600326S, PZP600327S, PZP600328S, PZP600331S, PZP600334S, PZP600335S, PZP600336S, PZP600338S, PZP600339S, PZP600340S, PZP600341S, PZP600342S, PZP600343S, PZP600345S, PZP600346S, PZP600347S, PZP600348S, PZP600350S thru PZP600394S, PZP600396S, PZP600397S, PZP600398S, PZP600399S, PZP600401S thru PZP600421S, PZP600423S, PZP600424S, PZP600425S, PZP600426S, PZP600427S, PZP600429S, PZP600430S, PZP600431S, PZP600432S, PZP600433S, PZP600434S, PZP600435S, PZP600436S, PZP600437S, PZP600438S, PZP600439S, PZP600440S, PZP600442S, PZP600443S, PZP600444S, PZP600448S, PZP600450S, PZP600452S, PZP600453S, PZP600454S, PZP600455S, PZP600456S, PZP600457S, PZP600458S, PZP600459S, PZP600462S thru PZP600618S, PZP600620S thru PZP600676S, PZP600678S thru PZP600729S, PZP600731S thru PZP600740S, PZP600742S, PZP600743S, PZP600745S thru PZP600795S, PZP600797S, PZP600798S, PZP600799S, PZP600800S, PZP600801S, PZP600802S, PZP600803S, PZP600804S, PZP600806S, PZP600807S, PZP600808S, PZP600809S, PZP600810S, PZP600811S, PZP600813S thru PZP600884, PZP600888S thru PZP601107S, PZP601109S thru PZP601127S, PZP601129S thru PZP601149S, PZP601152S thru PZP601165S, PZP601167S thru PZP601289S, PZP601291S thru PZP601340S, PZP601342S thru PZP601363S, PZP601365S, PZP601366S, PZP601367S, PZP601368S, PZP601369S, PZP601371S, PZP601372S, PZP601373S, PZP601375S, PZP601376S, PZP601377S, PZP601378S, PZP601379S, PZP601380S, PZP601381S, PZP601383S, PZP601384S, PZP601385S, PZP601387S thru PZP601423S, PZP601425S thru PZP601648S, PZP601650S thru PZP601825S, PZP601827S thru PZP601879S, PZP601881S thru PZP602022S, PZP602024S thru PZP602139S, PZP602141S thru PZP602196S, PZP602198S thru PZP602309S, PZP602311S thru PZP602426S, PZP602428S thru PZP602631S, PZP602633S thru PZP602723S, PZP602725S thru PZP602743S, PZP602745S, PZP602746S, PZP602747S, PZP602748S, PZP602749S, PZP602751S thru PZP602971S, PZP602973S, PZP602974S, PZP602975S, PZP602976S, PZP602977S, PZP602978S, PZP602979S, PZP602981S thru PZP602998S, PZP603000S thru PZP603406S, PZP603408S thru PZP603537S, PZP603539S thru PZP603587S, PZP603589S thru PZP603654S, PZP603656S, PZP603657S, PZP603658S, PZP603659S, PZP603660S, PZP603661S, PZP603663S, PZP603664S, PZP603665S, PZP603666S, PZP603667S, PZP603668S, PZP603669S, PZP603670S, PZP603671S, PZP603672S, PZP603674S thru PZP603981S, PZP603983S thru PZP604206S, PZP604208S thru PZP604399S, PZP604401S thru PZP604486S, PZP604488S thru PZP604556S, PZP604558S thru PZP604593S, PZP604595S thru PZP604901S, PZP604903S thru PZP605233S, PZP605235S thru PZP605450S, PZP605452S thru PZP605755S, PZP605757S thru PZP605786S, PZP605788S thru PZP605871S, PZP605873S thru PZP605989S, PZP605991S thru PZP606109S, PZP606111S thru PZP606164S, PZP606166S thru PZP606244S, PZP606246S thru PZP606276S, PZP606278S thru PZP606307S, PZP606309S thru PZP606542S, PZP606544S thru PZP606673S, PZP606676S thru PZP606940S, PZP606942S thru PZP606979S, PZP606981S thru PZP607092S, PZP607094S thru PZP607115S, PZP607117S thru PZP607176S, PZP607192S, PZP607194S, PZP607200S thru PZP607208S,
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul, Minnesota 55112
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Medtronic is informing you of a rare device software issue in certain ICD and CRT-D devices. A software update will be available to correct his issue. There have been 5 reports of this issue occurring with no reported patient injuries or deaths. Medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. In the u
FDA Determined
Cause 2
DESIGN: Software Design
Action Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected. For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
Quantity in Commerce 16910
Distribution Worldwide Distribution - USA, Puerto Rico, Virgin Islands, and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, and Viet Nam.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NIK and Applicant = MEDTRONIC INC.
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