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U.S. Department of Health and Human Services

Class 2 Device Recall SJM Confirm, Implantable Cardiac Monitor (ICM)

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  Class 2 Device Recall SJM Confirm, Implantable Cardiac Monitor (ICM) see related information
Date Initiated by Firm March 31, 2011
Date Posted July 05, 2011
Recall Status1 Terminated 3 on July 19, 2011
Recall Number Z-2733-2011
Recall Event ID 58686
510(K)Number K081365  
Product Classification Implantable Cardiac Monitor (without arrythmia detection) - Product Code MXC
Product SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE).

This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia
Code Information Confirm DM2100, DM2102 (IDE). Software Version 10.1.1.2
Recalling Firm/
Manufacturer		 St Jude Medical CRMD
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact
818-362-6822
Manufacturer Reason
for Recall		 The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the devices sensing algorithm. These enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. The user is presented with the option to upgrade new software into the SJM Confirm ICM
FDA Determined
Cause 2		 Software change control
Action St. Jude Cardiac Rhythm Management Division sent an "Important Product Correction" letter on March 25, 2011 to all affected customers. The letter explains the reason for the recall and provided recommendations including a software upgrade by SJM Field Clinical Engineer or Technical Services. Customers were recommended to fill out and return a "Physician Acknowledgement Form". For additional information please contact your local St.Jude Medical Sales Representative, Field Clinical Engineer or the Technical Services Department at 800-722-3774
Quantity in Commerce 83 units
Distribution Worldwide distribution: (USA) Nationwide including the States of CA, WA, FL, WV, NY, MD and LA, and the country of Germany
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.
510(K) Database 510(K)s with Product Code = MXC and Original Applicant = ST. JUDE MEDICAL
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