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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 11, 2007
Recall Status1 Terminated 3 on October 08, 2010
Recall Number Z-0037-2008
Recall Event ID 38371
PMA Number P970004 
Product Classification Implantable Neurostimulator for Urinary Control - Product Code EZW
Product Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implantable Neurostimulator for Urinary Control.
Code Information All serial numbers within these catalog/model numbers are affected: Model 3058, Catalog # 8870MM01 & 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		 A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant .
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 mangement of 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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