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U.S. Department of Health and Human Services

Class 2 Device Recall Intellis" Implantable Neurostimulator with AdaptiveStim" Technology

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 Class 2 Device Recall Intellis" Implantable Neurostimulator with AdaptiveStim" Technologysee related information
Date Initiated by FirmMarch 28, 2024
Date PostedApril 26, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1691-2024
Recall Event ID 94338
PMA NumberP840001 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
ProductIntellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Code Information UDI/DI 00643169781719
FEI Number 2182207
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
Manufacturer Reason
for Recall		inability to reprogram one device
FDA Determined
Cause 2		Under Investigation by firm
ActionMedtronic issued an URGENT FIELD SAFETY NOTICE to its sole consignee on 03/28/2024 via via an in-person delivery of the customer letter by the Technical Services Representative. The notice explained the issue and risk of resetting the device. Also included were trouble shooting steps and a factory reset to be initiated by Medtronic upon the implanting physicians' authorization.
Quantity in Commerce1 unit
DistributionInternational distribution in the country of UK.
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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