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U.S. Department of Health and Human Services

Class 2 Device Recall Interstim for Urinary Control

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  Class 2 Device Recall Interstim for Urinary Control see related information
Date Initiated by Firm June 25, 2007
Date Posted October 12, 2007
Recall Status1 Terminated 3 on October 08, 2010
Recall Number Z-0040-2008
Recall Event ID 44740
PMA Number P970004 
Product Classification Implantable Neurostimulator for Urinary Control. - Product Code EZW
Product Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for Urinary Control.
Code Information All serial numbers within these catalog/model numbers are affected (Model 3023, Catalog Number 8870MMB01 and 8870NNB01)
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
For Additional Information Contact
763-514-5174
Manufacturer Reason
for Recall		 Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).
FDA Determined
Cause 2		 Software design
Action Begining on July 11, 2007 a letter to the physicians was sent informing them of the issue and patient management for the two issues. The letter includes a Cover Letter, A Reply Form, and two Recall letters explaining the issue in detail.
Quantity in Commerce 1885
Distribution Nationwide and the Netherlands.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = EZW and Original Applicant = MEDTRONIC NEUROMODULATION
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