Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Intellis" Implantable Neurostimulator with AdaptiveStim" Technology see related information
Date Initiated by Firm March 28, 2024
Date Posted April 26, 2024
Recall Status1 Open3, Classified
Recall Number Z-1691-2024
Recall Event ID 94338
PMA Number P840001 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Code Information UDI/DI 00643169781719
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
Action Medtronic 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 Commerce 1 unit
Distribution International distribution in the country of UK.
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
-
-