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U.S. Department of Health and Human Services

Class 2 Device Recall Intellis" Clinician Programmer Application

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  Class 2 Device Recall Intellis" Clinician Programmer Application see related information
Date Initiated by Firm December 19, 2023
Date Posted January 22, 2024
Recall Status1 Open3, Classified
Recall Number Z-0780-2024
Recall Event ID 93714
PMA Number P840001 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Model A710 Intellis Clinician Programmer Application, version 2.0.97
Code Information UDI/DI 00763000520076, S/N: NPL1000519
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Jeffrey Trauring
763-514-2000
Manufacturer Reason
for Recall		 Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.
FDA Determined
Cause 2		 Under Investigation by firm
Action OUS communication to a single German consignee will be initiated via regionally approved methods beginning 19-Dec-2023. A field service technician will go to the site and reset the INS to resolve the issue.
Quantity in Commerce 1 tablet
Distribution Germany
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 = LGW and Original Applicant = MEDTRONIC NEUROMODULATION
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