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 |
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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.
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PMA Database | PMAs with Product Code = MHY
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