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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic SynchroMed II

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 Class 1 Device Recall Medtronic SynchroMed II see related information
Date Posted August 29, 2011
Recall Status1 Terminated on August 24, 2012
Recall Number Z-3043-2011
Recall Event ID 59317
PMA Number P860004S056 
Product Classification implantable infusion pump - Product Code LKK
Product Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.
Code Information 450557H, NGV450558H, NGV450563H, NGV450565H, NGV450566H, NGV450567H, NGV450568H, NGV450570H, NGV450572H, NGV450573H, NGV450574H, NGV450576H, NGV450580H, NGV450582H, NGV450583H, NGV450584H, NGV450585H, NGV450586H, NGV450587H, NGV450588H, NGV450589H, NGV450592H, NGV450594H, NGV450595H, NGV450597H, NGV450600H, NGV450601H, NGV450602H, NGV450603H, NGV450604H, NGV450605H, NGV450606H, NGV450608H, NGV450609H, NGV450612H, NGV450615H, NGV450616H, NGV450617H, NGV450618H, NGV450619H, NGV450621H, NGV450622H, NGV450623H, NGV450625H, NGV450626H, NGV450633H, NGV450634H, NGV450637H, NGV450638H, NGV450639H, NGV450640H, NGV450641H, NGV450642H, NGV450643H, NGV450644H, NGV450646H thru NGV450664H, NGV450666H thru NGV450675H, NGV450677H, NGV450678H, NGV450680H, NGV450681H, NGV450682H, NGV450683H, NGV450684H, NGV450686H, NGV450688H, NGV450689H, NGV450692H, NGV450693H, NGV450694H, NGV450696H, NGV450697H, NGV450700H, NGV450701H, NGV450702H, NGV450703H, NGV450704H, NGV450705H, NGV450706H, NGV450708H, NGV450709H, NGV450710H, NGV450711H, NGV450712H, NGV450713H, NGV450714H, NGV450715H, NGV450716H, NGV450717H, NGV450718H, NGV450720H, NGV450721H, NGV450723H, NGV450724H, NGV450725H, NGV450726H, NGV450727H, NGV450728H, NGV450729H, NGV450730H, NGV450732H, NGV450733H, NGV450735H, NGV450736H, NGV450738H, NGV450739H, NGV450740H, NGV450742H, NGV450744H, NGV450745H, NGV450747H, NGV450749H, NGV450750H, NGV450751H, NGV450753H, NGV450754H, NGV450755H, NGV450756H, NGV450758H, NGV450759H, NGV450760H, NGV450761H, NGV450763H, NGV450764H, NGV450766H, NGV450767H, NGV450768H, NGV450770H, NGV450771H, NGV450772H, NGV450773H, NGV450774H, NGV450775H, NGV450778H, NGV450779H, NGV450780H, NGV450781H, NGV450782H, NGV450785H, NGV450792H, NGV450794H, NGV450796H, NGV450798H, NGV450799H, NGV450800H, NGV450801H, NGV450803H, NGV450805H, NGV450807H, NGV450809H, NGV450811H, NGV450812H, NGV450813H, NGV450814H, NGV450815H, NGV450816H, NGV450817H, NGV450818H, NGV450819H, NGV450820H, NGV450821H, NGV450822H, NGV450824H, NGV450825H, NGV450826H, NGV450827H, NGV450828H, NGV450829H, NGV450830H, NGV450832H, NGV450833H, NGV450834H, NGV450835H, NGV450836H, NGV450837H, NGV450838H, NGV450839H, NGV450840H, NGV450841H, NGV450842H, NGV450843H, NGV450845H thru NGV450859H, NGV450861H, NGV450863H, NGV450864H, NGV450866H, NGV450869H, NGV450870H, NGV450871H, NGV450872H, NGV450874H, NGV450883H, NGV450884H, NGV450885H, NGV450889H, NGV450891H, NGV450895H, NGV450899H, NGV450900H, NGV450904H, NGV450905H, NGV450906H, NGV450907H, NGV450914H, NGV450915H, NGV450921H, NGV450923H, NGV450926H, NGV450928H, NGV450930H, NGV450934H, NGV450938H, NGV450939H, NGV450942H, NGV450947H, NGV450950H, NGV450951H, NGV450952H, NGV450954H, NGV450959H, NGV450960H, NGV450961H, NGV450963H, NGV450964H, NGV450965H, NGV450966H, NGV450967H, NGV450968H, NGV450970H, NGV450976H, NGV450979H, NGV450981H thru NGV451007H, NGV451011H, NGV451013H, NGV451014H, NGV451015H, NGV451016H, NGV451017H, NGV451019H, NGV451020H, NGV451021H, NGV451024H, NGV451027H, NGV451029H, NGV451031H, NGV451034H, NGV451035H, NGV451037H, NGV451038H, NGV451039H, NGV451040H, NGV451041H, NGV451042H, NGV451043H, NGV451044H, NGV451045H, NGV451046H, NGV451047H, NGV451051H, NGV451052H, NGV451055H, NGV451056H, NGV451058H, NGV451059H, NGV451060H, NGV451062H, NGV451065H, NGV451066H, NGV451068H, NGV451073H, NGV451075H, NGV451076H, NGV451077H, NGV451078H, NGV451080H, NGV451082H, NGV451083H, NGV451084H, NGV451085H, NGV451087H, NGV451088H, NGV451089H, NGV451090H, NGV451092H, NGV451093H, NGV451094H, NGV451097H, NGV451099H, NGV451100H, NGV451102H, NGV451103H, NGV451104H, NGV451106H, NGV451107H, NGV451108H, NGV451111H, NGV451112H, NGV451114H, NGV451115H, NGV451116H, NGV451119H, NGV451120H, NGV451121H, NGV451122H, NGV451123H, NGV451125H, NGV451126H, NGV451127H, NGV451130H, NGV451132H, NGV451133H, NGV451135H, NGV451139H, NGV451142H, NGV451143H, NGV451145H, NGV451148H, NGV451149H, NGV451150H, NGV451151H, NGV451152H, NGV451153H, NGV451154H, NGV451155H, NGV451158H, NGV451160H, NGV451161H, NGV451163H, NGV
Recalling Firm/
Manufacturer
Medtronic, Inc. - Neuromodulation
7000 Central Ave NE
Minneapolis MN 55432-3568
763-514-2000
For Additional Information Contact Medtronic Patient Services
800-510-6735
Manufacturer Reason
for Recall
Medtronic is updating information regarding the potential for reduced battery performance that can lead to sudden loss of therapy in a small percentage of Medtronic Model 8647 SynchroMed II pumps that was communicated with Healthcare providers in July 2009. The purpose of the current communication is to provide updated information regarding the scope and occurrence of this issue and to emphasize
FDA Determined
Cause 2
Component design/selection
Action Medtronic Neuromodulation notified physicians with an Urgent Medical Device Correction letter beginning July 05, 2011. A press was issued July 08, 2011. The letter described the issue, severity, recommendations if they notice issue, and patient management recommendations. UPDATE: in November 2011, MDT began to exchange unused pumps in inventory with pumps that contained the new battery. A letter dated November 2011 was left behind at locations in which the MDT representative swapped out the devices.
Quantity in Commerce 139,653 (105,002 US, 34,61 OUS)
Distribution Worldwide including USA, Puerto Rico, Algeria, Aruba, Australia, Austria, Belarus, Belgium, Brazil, Chile. Colombia. Costa Rica. Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, India, Iran Iraq, Ireland, Israel Italy, Jordan, Kuwait, Lebanon, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
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 = LKK and Original Applicant = MEDTRONIC INC.
PMAs with Product Code = LKK and Original Applicant = MEDTRONIC NEUROLOGICAL
PMAs with Product Code = LKK and Original Applicant = MEDTRONIC NEUROMODULATION
PMAs with Product Code = LKK and Original Applicant = MEDTRONIC VASCULAR
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