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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic DBS Extension Kit for

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  Class 2 Device Recall Medtronic DBS Extension Kit for see related information
Date Initiated by Firm April 16, 2015
Date Posted May 15, 2015
Recall Status1 Terminated 3 on July 22, 2016
Recall Number Z-1617-2015
Recall Event ID 71016
PMA Number P960009 
Product Classification Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Product Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Code Information all Serial numbers
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Technical Services
800-707-0933
Manufacturer Reason
for Recall		 Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa¿ PC (Model 37601), Activa¿ RC (Model 37612), and the Activa¿ SC (Model 37603).
FDA Determined
Cause 2		 Under Investigation by firm
Action Medtronic began notifying consignees with an Urgent Medical Device Safety Notification letter beginning April 16, 2015. Consignees will be notified by mail and/or in person, by visit of a Medtronic field representative. The letter described the issue and provided recommendations of following the instructions defined within the Neurostimulator implant manual. A Physician Reply Form was asked to be returned via fax at 800-897-3899 or email to neuro.quality@medtronic.com. Consignees with questions can contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.
Quantity in Commerce 86,851 (US 37,933 / OUS 48,918)
Distribution worldwide
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 = MHY and Original Applicant = MEDTRONIC Inc.
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