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U.S. Department of Health and Human Services

Class 2 Device Recall Activa PC

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  Class 2 Device Recall Activa PC see related information
Date Initiated by Firm July 14, 2014
Date Posted August 18, 2014
Recall Status1 Terminated 3 on October 06, 2014
Recall Number Z-2259-2014
Recall Event ID 68935
PMA Number P960009S052 
Product Classification Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Product Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only.

The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain.
Code Information Serial numbers: NKM724776H, NKM724782H, NKM724785H,  NKM724790H, NKM724802H, NKM724843H.
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Medtronic Representative
800-633-8766
Manufacturer Reason
for Recall		 Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.
FDA Determined
Cause 2		 Process control
Action The firm, Medtronic, notified their Consignees on 07/14/2014 via telephone of the recall. Medtronic representative used telephone script to convey the information. The script was directed to Risk Management or Inventory Management. The caller was to inform consignees of the problem and product being recalled. Advised consignees to quarantine the product and provided the Medtronic Device Removal Reply Form to the consignees via e-mail or Fax. The Reply Form included contact information which was to call 1-800-633-8766 in case they needed to contact a Medtronic representative. The completed form is to be faxed back to 1-800-897-3899 or e-mail a PDF to neuro.quality@medtronic.com. If you have any questions, call 763-526-1294.
Quantity in Commerce 6
Distribution Distributed in the states of: MA, NC, OH, and 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 = MHY and Original Applicant = MEDTRONIC Inc.
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