Class 1 Device Recall Medtronic SIGMA 100/200/300 Series IPGs

• Date Initiated by Firm: May 18, 2009
• Date Posted: June 11, 2009
• Recall Status: Terminated on March 28, 2012
• Recall Number: Z-1518-2009
• Recall Event ID: 52076
• PMA Number: P980035S029
• Product Classification: Implantable Pacemakere Pulse-Generator - Product Code DXY
• Product: Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker, model SVVI103, for ventricular use only.
• Code Information: Model SVVI103, serial numbers: PJG159902H, PJG159903H, PJG159904H, PJG159906H, PJG159909H, PJG159910H, PJG159912H, PJG159913H, PJG159916H, PJG159918H, PJG159922H, PJG159926H, PJG159929H, PJG159932H, PJG159935H, PJG159936H, PJG159939H, PJG159941H, PJG159943H, PJG159944H, PJG159945H, PJG159948H, PJG159952H, PJG159954H, PJG159956H, PJG159957H, PJG159960H, PJG159961H, PJG159962H, PJG159964H, PJG159966H, PJG159968H, PJG159971H, PJG159972H, PJG159973H, PJG159974H, PJG159976H, PJG159977H, PJG159979H, PJG159981H, PJG159982H, PJG159983H, PJG159985H, PJG159988H, PJG159989H, PJG159990H, PJG159993H, PJG159996H, PJG159997H, PJG159999H, PJG160000H, PJG160003H, PJG160004H, PJG160005H, PJG160006H, PJG160007H, PJG160008H, PJG160009H, PJG160010H, PJG160011H, PJG160018H, PJG160020H, PJG160026H, PJG160027H, PJG160039H, PJG160040H, PJG160151H, PJG160152H, PJG160153H, PJG160155H, PJG160156H, PJG160158H, PJG160159H, PJG160160H, PJG160161H, PJG160163H, PJG160165H, PJG160167H, PJG160171H, PJG160722H, PJG160723H, PJG160724H, PJG160725H, PJG160726H, PJG160727H, PJG160728H, PJG160729H, PJG160730H, PJG160731H, PJG160732H, PJG160733H, PJG160734H, PJG160735H, PJG160736H, PJG160737H, PJG160738H, PJG160739H, PJG160740H, PJG160741H, PJG160742H, PJG160743H, PJG160744H, PJG160745H, PJG160746H, PJG160747H, PJG160748H, PJG160749H, PJG160751H, PJG160752H, PJG160753H, PJG160754H, PJG160755H, PJG160756H, PJG160757H, PJG160758H, PJG160759H, PJG160760H, PJG160761H, PJG160762H, PJG160763H, PJG160764H, PJG160765H, PJG160766H, PJG160767H, PJG160768H, PJG160769H, PJG160770H, PJG160771H, PJG160772H, PJG160773H, PJG160775H, PJG160776H, PJG160777H, PJG160778H, PJG160779H, PJG160780H, PJG160781H, PJG160782H, PJG160783H, PJG160784H, PJG160785H, PJG160786H, PJG160787H, PJG160788H, PJG160789H, PJG160790H, PJG160791H, PJG160792H, PJG160793H, PJG160794H, PJG160795H, PJG160796H, PJG160797H, PJG160798H, PJG160799H, PJG160800H, PJG160801H, PJG160802H, PJG160803H, PJG160804H, PJG160805H, PJG160806H, 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PJG162627H, PJG162629H, PJG162630H, PJG162631H, PJG162632H, PJG162633H, PJG162634H, PJG162635H, PJG162636H, PJG162637H, PJG162639H, PJG162640H, PJG162641H, PJG162642H, PJG162643H, PJG162644H, PJG162645H, PJG162646H, PJG162647H, PJG162648H, PJG162649H, PJG162650H, PJG162651H, PJG162652H, PJG162653H, PJG162654H, PJG162655H, PJG162656H, PJG162657H, PJG162658H, PJG162659H, PJG162660H, PJG162661H, PJG162662H, PJG162663H, PJG162664H, PJG162665H, PJG162666H, PJG162667H, PJG162668H, PJG162670H, PJG162671H, PJG162672H, PJG162673H, PJG162674H, PJG162675H, PJG162676H, PJG162677H, PJG162678H, PJG162679H, PJG162680H, PJG162681H, PJG162682H, PJG162683H, PJG162684H, PJG162685H, PJG162686H, PJG162687H, PJG162688H, PJG162689H, PJG162690H, PJG162691H, PJG162692H, PJG162693H, PJG162694H, PJG162695H, PJG162696H, PJG162697H, PJG162698H, PJG162699H, PJG162700H, PJG162701H, PJG162702H, PJG162703H, PJG162704H, PJG162705H, PJG162706H, PJG162707H, PJG162708H, PJG162709H, PJG162710H, PJG162711H, PJG162712H, 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PJG751171S, PJG751178S, PJG751181S, PJG751186S, PJG751191S, PJG751192S, PJG751193S, PJG751196S, PJG751197S, PJG751198S, PJG751200S, PJG751202S, PJG751213S, PJG751218S, PJG751223S, PJG751232S.PJG751239S, PJG751243S, PJG751246S, PJG751252S, PJG751265S, PJG751268S, PJG751274S, PJG751275S, PJG751284S, PJG751307S, PJG751309S, PJG751325S, PJG751327S, PJG751333S, PJG751772C, PJG751776C, PJG751777C, PJG751786C, PJG751792C, PJG751794C, PJG751798C, PJG751800C, PJG751802C, PJG751808C, PJG751809C, PJG751834C, PJG751840C, PJG751863C, PJG751873C, PJG751904C, PJG751911C, PJG751919C, PJG753026S, PJG753037S, PJG753048S, PJG753050S, PJG753060S, PJG753063S, PJG753064S, PJG753081S, PJG753086S, PJG753096S, PJG753098S, PJG753100S, PJG753117S, PJG753120S, PJG753121S, PJG753125S, PJG753411S, PJG753416S, PJG753422S, PJG753424S, PJG753425S, PJG753426S, PJG753427S, PJG753431S, PJG753434S, PJG753435S, PJG753436S, PJG753437S, PJG753439S, PJG753441S, PJG753445S, PJG753447S, PJG753449S, PJG753450S, PJG753451S, PJG753458S, PJG753461S, PJG753463S, PJG753469S, PJG753470S, PJG753471S, PJG753473S, PJG753476S, PJG753478S, PJG753479S, PJG753480S, PJG753481S, PJG753485S, PJG753486S, PJG753487S, PJG753488S, PJG753489S, PJG753490S, PJG753496S, PJG753497S, PJG753502S, PJG753505S, PJG753506S, PJG753508S, PJG753509S, PJG753511S, PJG753513S, PJG753515S, PJG753517S, PJG753518S, PJG753519S, PJG753521S, PJG753522S, PJG753523S, PJG753525S, PJG753526S, PJG753587S, PJG753588S, PJG753589S, PJG753590S, PJG753591S, PJG753592S, PJG753594S, PJG753595S, PJG753596S, PJG753977S, PJG754027S, PJG754496S, PJG754501S, PJG754503S, PJG754504S, PJG754509S, PJG754511S, PJG754513S, PJG754517S, PJG754522S, PJG754525S, PJG754528S, PJG754534S, PJG754541S, PJG754544S, PJG754550S, PJG754551S, PJG754557S, PJG754558S, PJG754559S, PJG754564S, PJG754565S, PJG754567S, PJG754572S, PJG754575S, PJG754576S, PJG754581S, PJG754588S, PJG754589S, PJG754590S, PJG754591S, PJG754592S, PJG754593S, PJG754974C, PJG754999C, PJG755024C, PJG755028C, PJG755052C, PJG755079C, PJG755107C, PJG755118C, PJG755128C, PJG755130C, PJG755171C, and PJG755468S.
• Recalling Firm/ Manufacturer: Medtronic Inc. Cardiac Rhythm Disease Managment; 8200 Coral Sea St. N.E.; Saint Paul MN 55112
• For Additional Information Contact: 763-514-4000
• Manufacturer Reason for Recall: One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.
• FDA Determined Cause: Device Design
• Action: Medtronic Sales representative hand delivered an Important Patient Safety Information letter, dated May 2009, to physicians beginning 05/18/09. The letter describes the issues, provides a predicted failure rate for the 3 populations of devices, and provides Patient Management Recommendations. The letter recommended that physicians should advise their patients to seek medical attention immediately if they experience symptoms (e.g., fainting or lightheadedness). It was also recommended that physicians should consider device replacement for patients who are both pacemaker dependent and who have been implanted with a device in the affected subsets. Medtronic will offer supplemental device warranty if the device is not already at elective replacement time. The last recommendation was that physicians should continue routine follow up in accordance with standard practice for those patients who are not pacemaker dependent. The letter also provides Physician and Patient Support. Letters will be mailed to patients with registered devices beginning 05/27/09. Questions should be directed to a local Medtronic Representative or Medtronic Technical Services at 800-505-4636.
• Quantity in Commerce: 3822
• Distribution: Worldwide Distribution -- USA, including Washington D.C., Guam, Puerto Rico, and Virgin Islands; Albania, Algeria, Argentina, Armenia, Aruba, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latin America, Latvia, Lebanon, Luxembourg, Martinique, Mauritius, Mexico, Morocco, Nepal, Netherlands, Netherlands Antilles, Norway, Oman, Pakistan, Palestinian Territory Occupied, Peru, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Senegal, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Vatican City State (Holy See), and Venezuela.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = DXY and Original Applicant = MEDTRONIC Inc.