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U.S. Department of Health and Human Services

Class 2 Device Recall Viatron CSeries dual chamber Rate Responsive Pacemakers

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  Class 2 Device Recall Viatron CSeries dual chamber Rate Responsive Pacemakers see related information
Date Initiated by Firm February 05, 2007
Date Posted July 07, 2007
Recall Status1 Terminated 3 on October 16, 2008
Recall Number Z-0999-2007
Recall Event ID 37587
PMA Number P990001 
Product Classification Pacemakers - Product Code NVZ
Product Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the following models: C60A1 and C60A3. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing using an accelerometer) for permanent atrial and ventricular pacing. C-series software is VSF11/VSF12 Version 1.0. Vitatron is a division of Medtronic, Inc., Sales Office is Vitatron USA, 7000 Central Ave., NE, Minneapolis, MN 55423-3576. The head office is Vitatron B.V., P.O. Box 5227, 6802 EE Arnhem, The Netherlands.
Code Information All lots/serial numbers
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Managment
7000 Central Ave Ne
Minneapolis MN 55432-3568
Manufacturer Reason
for Recall		 Pacing rate; Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient's intrinsic rate falls below the programmed lower rate.
FDA Determined
Cause 2		 Software design
Action Advisory letters to physicians were mailed in February 2007. Sales respresentatives will follow-up with physicians by visit. A programmer software update will be released upon regulatory approval. The Advisory Letter provided short-term direction to reduce problems pending software upgrades.
Quantity in Commerce 4,294
Distribution within the US to include: AL, AR, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, NC, ND, NJ, NY, OH, OK, SC, TX.
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 = NVZ and Original Applicant = MEDTRONIC Inc.
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