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U.S. Department of Health and Human Services

Class 2 Device Recall Intellis Spinal Cord Stimulator

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  Class 2 Device Recall Intellis Spinal Cord Stimulator see related information
Date Initiated by Firm November 12, 2020
Create Date January 14, 2021
Recall Status1 Open3, Classified
Recall Number Z-0860-2021
Recall Event ID 86872
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.
Code Information Software version 1.3.80
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Medtronic Neuromodulation Technical Services*
800-707-0933
Manufacturer Reason
for Recall		 A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Medtronic notified the first consignee by letter on 11/12/2020 with a confirmation of their complaint and request to perform a correction to the device which put the device in a factory-reset state and restore functionality to allow programming and continued therapy. On 17 Dec 2020, Medtronic will begin issuing an Urgent Medical Device Correction notification to physicians regarding this validation error and providing instructions on the impact and appropriate mitigating actions if this issue presents.
Quantity in Commerce 7960 downloads
Distribution Worldwide distribution - US Nationwide distribution and the countries of Canada, Latin America, Asia Pacific, Japan, China, and European regions.
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.
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