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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 Applicationsee related information
Date Initiated by FirmDecember 19, 2023
Date PostedJanuary 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0780-2024
Recall Event ID 93714
PMA NumberP840001 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
ProductModel A710 Intellis Clinician Programmer Application, version 2.0.97
Code Information UDI/DI 00763000520076, S/N: NPL1000519
FEI Number 2182207
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information ContactJeffrey 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
ActionOUS 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 Commerce1 tablet
DistributionGermany
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = LGW
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