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U.S. Department of Health and Human Services

Class 2 Device Recall Maximo II DR

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 Class 2 Recall
Maximo II DR
see related information
Date Posted October 21, 2010
Recall Status1 Terminated on March 15, 2012
Recall Number Z-0113-2011
Recall Event ID 55922
Premarket Approval
PMA Number
P980016/S114
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Medtronic Maximo II DR, model D284DRG. Digital dual chamber implantable cardioverter defibrillator (VVE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA. The Dual chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia 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). The device responds to bradyarrhythmias by providing bradycardia pacing therapies.
Code Information Model D284DRG, serial numbers: PZM200002H thru PZM200043H, PZM200045H, PZM200046H, PZM200047H, PZM200049H thru PZM200110H, PZM200112H thru PZM200161H, PZM200163H thru PZM200231H, PZM200233H, PZM200234H, PZM200235H, PZM200236H, PZM200237H, PZM200238H, PZM200239H, PZM200240H, PZM200242H thru PZM200261H, PZM200263H, PZM200264H, PZM200265H, PZM200267H thru PZM200401H, PZM200403H, PZM200405H thru PZM200426H, PZM200428H thru PZM200438H, PZM200440H thru PZM200540H, PZM200542H thru PZM200571H, PZM200573H thru PZM200585H, PZM200587H thru PZM200608H, PZM200610H, PZM200611H, PZM200612H, PZM200613H, PZM200614H, PZM200615H, PZM200616H, PZM200618H thru PZM200692H, PZM200694H thru PZM200762H, PZM200764H thru PZM200830H, PZM200832H, PZM200833H, PZM200834H, PZM200835H, PZM200836H, PZM200837H, PZM200839H, PZM200840H, PZM200841H, PZM200842H, PZM200843H, PZM200844H, PZM200845H, PZM200846H, PZM200847H, PZM200849H thru PZM201122H, PZM201124H thru PZM201290H, PZM201292H, PZM201293H, PZM201294H, PZM201295H, PZM201296H, PZM201297H, PZM201299H, PZM201300H, PZM201301H, PZM201302H, PZM201303H, PZM201304H, PZM201305H, PZM201306H, PZM201307H, PZM201308H, PZM201309H, PZM201310H, PZM201312H thru PZM201335H, PZM201337H thru PZM201390H, PZM201392H thru PZM201411H, PZM201413H thru PZM201431H, PZM201433H thru PZM201459H, PZM201461H thru PZM201567H, PZM201569H thru PZM201645H, PZM201647H thru PZM201692H, PZM201694H, PZM201696H thru PZM201709H, PZM201711H, PZM201712H, PZM201713H, PZM201714H, PZM201715H, PZM201717H thru PZM201794H, PZM201796H, PZM201797H, PZM201799H, PZM201801H, PZM201802H, PZM201803H, PZM201804H, PZM201805H, PZM201806H, PZM201808H thru PZM201860H, PZM201862H thru PZM201995H, PZM201998H, PZM202001H, PZM202002H, PZM202003H, PZM202004H, PZM202005H, PZM202008H, PZM202010H, PZM202011H, PZM202013H, PZM202014H, PZM202016H thru PZM202041H, PZM202044H, PZM202045H, PZM202046H, PZM202047H, PZM202049H thru PZM202066H, PZM202068H, PZM202069H, PZM202070H, PZM202071H, PZM202072H, PZM202074H, PZM202076H thru PZM202090H, PZM202092H, PZM202093H thru PZM202158H, PZM202160H, PZM202161H, PZM202162H, PZM202163H, PZM202164H, PZM202165H, PZM202166H, PZM202167H, PZM202168H, PZM202169H, PZM202171H, PZM202172H thru PZM202242H, PZM202244H thru PZM202299H, PZM202301H, PZM202302H, PZM202303H, PZM202304H, PZM202305H, PZM202306H, PZM202307H, PZM202309H thru PZM202370H, PZM202372H thru PZM202397H, PZM202399H thru PZM202423H, PZM202425H, PZM202426H, PZM202427H, PZM202428H, PZM202430H, PZM202431H, PZM202432H, PZM202433H, PZM202434H, PZM202435H, PZM202437H thru PZM202565H, PZM202567H thru PZM202647H, PZM202649H thru PZM202676H, PZM202678H thru PZM202700H, PZM202702H thru PZM202745H, PZM202747H, PZM202748H, PZM202750H, PZM202751H, PZM202752H, PZM202754H, PZM202755H, PZM202756H, PZM202757H, PZM202758H, PZM202759H, PZM202761H thru PZM202774H, PZM202776H thru PZM203008H, PZM203010H thru PZM203094H, PZM203096H, PZM203097H thru PZM203321H, PZM203323H thru PZM203374H, PZM203376H thru PZM203422H, PZM203424H thru PZM203518H, PZM203520H thru PZM203636H, PZM203638H thru PZM203818H, PZM203820H thru PZM203867H, PZM203869H thru PZM203902H, PZM203904H thru PZM204013H, PZM204015H thru PZM204095H, PZM204097H thru PZM204221H, PZM204223H thru PZM204272H, PZM204274H thru PZM204390H, PZM204391H, PZM204392H, PZM204394H, PZM204395H, PZM204397H thru PZM204410H, PZM204412H, PZM204413H, PZM204414H, PZM204415H, PZM204416H, PZM204417H, PZM204418H, PZM204419H, PZM204420H, PZM204421H, PZM204422H, PZM204424H thru PZM204492H, PZM204494H thru PZM204618H, PZM204620H thru PZM204820H, PZM204822H thru PZM204897H, PZM204899H thru PZM204913H, PZM204915H thru PZM204931H, PZM204933H thru PZM204999H, PZM205001H thru PZM205021H, PZM205023H, PZM205025H, PZM205026H thru PZM205045H, PZM205047H, PZM205048H, PZM205049H, PZM205050H, PZM205052H, PZM205053H, PZM205054H, PZM205055H, PZM205056H, PZM205058H thru PZM205095H, PZM205097H thru PZM205113H, PZM205115H thru PZM205174H, PZM205176H thru PZM205199H, PZM205201H thru PZM205247H, PZM205249H thru PZM205468H, PZM205470H, PZM205471H, PZM205472H, PZM205473H, PZM205474H, PZM205475H, PZM205476H, PZM205477H, PZM205478H, PZM205480H thru PZM205623H, PZM205625H thru PZM205638H, PZM205640H thru PZM205919H, PZM205921H, PZM205922H, PZM205923H, PZM205924H, PZM205926H thru PZM206030H, PZM206032H, PZM206033H thru PZM206077H, PZM206079H thru PZM206090H, PZM206092H thru PZM206105H, PZM206107H thru PZM206151H, PZM206153H thru PZM206210H, PZM206212H thru PZM206539H, PZM206541H thru PZM206799H, PZM206801H thru PZM206848H, PZM206850H thru PZM206907H, PZM206909Hthru PZM206918H, PZM206920H thru PZM206961H, PZM206963H thru PZM207106H, PZM207108H thru PZM207232H, PZM207234H thru PZM207276H, PZM207278H thru PZM207339H, PZM207341H thu PZM207428H, PZM207430H thru PZM207441H, PZM207443H thru PZM207564H, PZM207566H thru PZM207676H, PZM207678H thru PZM207693H, PZM207695H thru PZM207704H, PZM207706H thru PZM207805H, PZM207807H thru PZM207986H, PZM207988H thru PZM208082H, PZM208084H thru PZM208104H, PZM208106H thru PZM208143H PZM208145 thru PZM208151H, PZM208153H thru PZM208164H, PZM208166H, thru PZM208175H, PZM208177H thru PZM208189H, PZM208191H thru PZM208275H, PZM208277H thru PZM208371H, PZM208373H thru PZM208450H, PZM208452H thru PZM208563H, PZM208565H thru PZM208633H, PZM208635H thru PZM208780H, PZM208782H thru PZM209153H, PZM209155H thru PZM209250H, PZM209252H thru PZM209264H, PZM209266H thru PZM209282H, PZM209284H, PZM209285H, PZM209286H, PZM209287H, PZM209289H thru PZM209348H, PZM209350H thru PZM209382H, PZM209384H thru PZM209427H, PZM209429H thru PZM209496H, PZM209498H thru PZM209512H, PZM209514H, PZM209517H, thru PZM209568H, PZM209570H thru PZM209658H, PZM209660H, PZM209661H, PZM209662H, PZM209663H, PZM209664H, PZM209666H thru PZM209819H, PZM209821H thru PZM209878H, PZM209880H thru PZM209908H, PZM209910H thru PZM209935H, PZM209937H, PZM209940H thru PZM209962H, PZM209964H thru PZM210010H, PZM210012H thru PZM210037H, PZM210039H thru PZM210404H, PZM210406H thru PZM210462H, PZM210464H thru PZM210505H, PZM210507H thru PZM210569H, PZM210571H thru PZM210606H, PZM210608H thru PZM210779H, PZM210781H thru PZM210837H, PZM210839H, PZM210840H, PZM210841H, PZM210843H, PZM210844H, PZM210845H, PZM210846H, PZM210847H, PZM210848H, PZM210849H, PZM210850H, PZM210852H thru PZM210903H, PZM210905H thru PZM210914H, PZM210916H thru PZM210956H, PZM210958H thru PZM211011H, PZM211013H thru PZM211038H, PZM211040H thru PZM211129H, PZM211131H, PZM211133H thru PZM211165H, PZM211167H thru PZM211254H, PZM211256H thru PZM211348H, PZM211350H thru PZM211414H, PZM211416H thru PZM211427H, PZM211429H thru PZM211521H, PZM211523H thru PZM211542H, PZM211544H thru PZM211710H, PZM211712H thru PZM211863H, PZM211865H thru PZM211953H, PZM211955H thru PZM212023H, PZM212025H thru PZM212157H, PZM212159H thru PZM212210H, PZM212212H thru PZM212278H, PZM212280H thru PZM212298H, PZM212300H, PZM212301H, PZM212302H, PZM212303H, PZM212304H, PZM212305H, PZM212307H thru PZM212324H, PZM212326H thru PZM212455H, PZM212456H, PZM212457H thru PZM212502H, PZM212504H thru PZM212541H, PZM212543H, PZM212545H, PZM212547H thru PZM212561H, PZM212564H, PZM212565H, PZM212566H, PZM212567H, PZM212568H, PZM212569H, PZM212570H, PZM212571H, PZM212572H, PZM212573H, PZM212574H, PZM212575H, PZM212576H, PZM212578H thru PZM212604H, PZM212606H thru PZM212624H, PZM212626H thru PZM212640H, PZM212642H thru PZM212703H, PZM212704H, PZM212705H, PZM212706H, PZM212707H, PZM212709H thru PZM212737H, PZM212739H, PZM212741H thru PZM212785H, PZM212787H, PZM212788H thru PZM212840H, PZM212843H, PZM212844H, PZM212845H, PZM212847H, PZM212848H, PZM212849H, PZM212850H, PZM212851H, PZM212852H, PZM212853H thru PZM212947H, PZM212949H thru PZM213085H, PZM213088H, PZM213091H thru PZM213106H, PZM213108H thru PZM213201H, PZM600001S thru PZM600047S, PZM600048S thru PZM600095S, PZM600097S thru PZM600126S, PZM600128S thru PZM600138S, PZM600140S thru PZM600194S, PZM600196S thru PZM600238S, PZM600240S thru PZM600295S, PZM600297S, PZM600298S thru PZM600321S, PZM600324S, PZM600328S, PZM600333S, PZM600336S, PZM600340S, PZM600343S, PZM600345S, PZM600348S, PZM600350S, PZM600352S, PZM600354S, PZM600355S, PZM600357S, PZM600358S, PZM600359S, PZM600364S, PZM600365S, PZM600368S, PZM600370S, PZM600373S, PZM600376S, PZM600385S, PZM600388S, PZM600390S, PZM600391S, PZM600392S, PZM600396S, PZM600397S, PZM600401S thru PZM600495S, PZM600497S, PZM600498S, PZM600500S thru PZM600563S, PZM600565S thru PZM600582S, PZM600584S thru PZM600604S, PZM600606S thru PZM600676S, PZM600678S, PZM600679S, PZM600680S, PZM600682S, PZM600683S thru PZM600728S, PZM600730S thru PZM600805S, PZM600807S, PZM600808S, PZM600809S, PZM600810S, PZM600811S, PZM600812S, PZM600813S, PZM600814S, PZM600816S thru PZM600837S, PZM600839S thru PZM600882S, PZM600884S thru PZM600907S, PZM600909S thru PZM601026S, PZM601028S thru PZM601040S, PZM601042S thru PZM601088S, PZM601090S thru PZM601248S, PZM601250S thru PZM601466S, PZM601468S thru PZM601523S, PZM601525S thru PZM601545S, PZM601547S thru PZM601592S, PZM601594S thru PZM601786S, PZM601788S, PZM601789S, PZM601790S, PZM601792S, PZM601793S, PZM601794S thru PZM601936S, PZM601938S thru PZM602099S, PZM602101S thru PZM602142S, PZM602144S, PZM602167S thru PZM602355S, PZM602357S thru PZM602445S, PZM602447S thru PZM603113S, PZM603115S thru PZM603339S, PZM603341S thru PZM603460S, PZM603462S thru PZM603525S, PZM603527S thru PZM603730S, PZM603732S thru PZM603845S, PZM603847S thru PZM603930S, PZM603932S, PZM603933S, PZM603934S, PZM603935S, PZM603937S thru PZM604046S, PZM604048S, PZM604049S thru PZM604104S, PZM604106S thru PZM604185S, PZM604187S thru PZM604197S, PZM604199S thru PZM604337S, PZM604339S thru PZM604399S, PZM604401S, PZM604402S, PZM604403S, PZM604404S, PZM604405S, PZM604406S, PZM604407S, PZM604408S, PZM604409S, PZM604410S, PZM604411S, PZM604413S thru PZM604496S, PZM604498S thru PZM604668S, PZM604670S thru PZM604737S, PZM604739S thru PZM605087S, PZM605089S thru PZM605110S, PZM605112S thru PZM605528S, PZM605530S thru PZM605622S, PZM605624S thru PZM605636S, PZM605638S thru PZM605678S, PZM605680S thru PZM605850S, PZM605852S thru PZM606000S, PZM606002S thru PZM606312S, PZM606315S thru PZM606328S, PZM606330S thru PZM606370S, PZM606372S thru PZM606662S, PZM606664S thru PZM606694S, PZM606696S thru PZM606709S, PZM606711S thru PZM607263S, PZM607265S thru PZM607284S, PZM607286S thru PZM607293S, PZM607295S thru PZM607320S, PZM607322S thru PZM607361S, PZM607363S thru PZM607430S, PZM607432S thru PZM607501S, PZM607503S thru PZM607544S, PZM607546S thru PZM607569S, PZM607571S, PZM607572S, PZM607573S, PZM607575S, PZM607577S, PZM607636S.
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 20421
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 = LWS and Applicant = MEDTRONIC INC.
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