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U.S. Department of Health and Human Services

Class 2 Device Recall Accent DR

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 Class 2 Recall
Accent DR
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on April 10, 2012
Recall Number Z-0429-2012
Recall Event ID 60134
Premarket Approval
PMA Numbers
P030035 P880086
Product Classification Implantable Pacemaker Pulse-Generator - Product Code DXY
Product Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
Code Information PM2110, 2112, 2210, 2212 (Accent DR) All lots and serial numbers
Recalling Firm/
Manufacturer
St Jude Medical CRMD
15900 Valley View Ct
Sylmar, California 91342-3577
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements.These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm, St. Jude Medical, sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated September 22, 2011 to its customers by FedEx priority overnight service for planned receipt on September 23, 2011. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed that in order to prevent a false reading, a new programmer software version (12.1.0.1) is available. This software when used to interrogate an Accent DR or Anthem CRT-P pacemaker will eliminate the potential for this anomaly to occur. The onetime upgrade is performed automatically on affected devices and will not change the operation of the implanted device. A St. Jude Medical Sales Representative will assist the customers in loading the new programmer software onto their Merlin programmer. Customers with questions or concerns, can contact their local St. Jude Medical representative or their Technical services department at (800) 722-3774.
Quantity in Commerce 152,000 units
Distribution Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Asia Pacific, Belgium, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latin America, Lebanon, Malaysia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, UK, and U.A.E.
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 = DXY and Applicant = ST. JUDE MEDICAL
PMAs with Product Code = DXY and Applicant = ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMAs with Product Code = DXY and Applicant = ST. JUDE MEDICAL, INC.
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