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U.S. Department of Health and Human Services

Class 2 Device Recall A610

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  Class 2 Device Recall A610 see related information
Date Initiated by Firm March 09, 2021
Create Date April 07, 2021
Recall Status1 Open3, Classified
Recall Number Z-1368-2021
Recall Event ID 87569
PMA Number P960009 
Product Classification Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Product A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and
3.0.1057*
* Version 3.0.1057 is approved for distribution in Europe only.
Code Information version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Lindsey Dickinson
763-514-2000
Manufacturer Reason
for Recall		 There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using the "replacement" function of the A610 clinician programmer application, the cycling feature is not copied properly. 2. Log Fill Issue: When the Percept PC INS System Event log is full, the clinician programmer A610 Software application version 2.0.4584, 2.0.4594, 2.0.4605, or 3.0.1057 crashes when it attempts a reading of the last records in the log.
FDA Determined
Cause 2		 Under Investigation by firm
Action Beginning 9-Mar-2021, Medtronic representatives began verbally notifications in order to inform impacted physicians of the issues and provide the mitigations outlined in the letters. Beginning 16-Mar-2021, Medtronic notified its consignees via mail, email, fax, and/or personal visit by Medtronic personnel. The notice described the problems and provided a workaround to use until a software update is available.
Quantity in Commerce 5332 downloads
Distribution Worldwide distribution - US Nationwide distribution in Puerto Rico and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Lithuania, Luxembourg, Malaysia, Malta, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MHY and Original Applicant = MEDTRONIC Inc.
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