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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Sprint Quattro Secure S, model 6935

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  Class 2 Device Recall Medtronic Sprint Quattro Secure S, model 6935 see related information
Date Initiated by Firm October 25, 2010
Date Posted November 26, 2010
Recall Status1 Terminated 3 on February 04, 2012
Recall Number Z-0474-2011
Recall Event ID 57090
PMA Number P920015S039 
Product Classification Implantable cardioverter defibrillator (non-crt) - Product Code LWS
Product Medtronic Sprint Quattro Secure S, model 6935. Steroid eluting, tripolar, screw-in, ventricular lead with RV defibrillation coil electrode. Contents Sterile. Manufactured in: Villalba, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 U.S.A.
Code Information all devices are affected, however, it is an issue that can present itself only at the time of the surgical procedure (acute issue) and it doesn't affect teh chronic performance of a successfully implanted lead.
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
For Additional Information Contact Medtronic Technical Services
800-723-4636
Manufacturer Reason
for Recall		 Over--retraction of the helix during initial implant or subsequent repositioning may result in the inability to extend the helix. This does not impact acute or chronic performance of successfully implanted leads.
FDA Determined
Cause 2		 Device Design
Action Medtronic issued an Important Medical Device Correction letter, dated October 2010, to doctors. The letter contains a Performance Note. The letter describes the issue and the performance note provides information on how to mitigate the issue through replacement with a new lead. Customers can contact Medtronic Technical Services at 800 723-4636
Quantity in Commerce 154,000 total
Distribution Worldwide Distribution: Throughout the US, including Guam, Puerto Rico, and US Virgin Islands, and to the countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bangladesh, Barbados, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Viet Nam.
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 = LWS and Original Applicant = MEDTRONIC Inc.
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