Recalls / —
—#64346
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.
- FDA product code
- EZW — Stimulator, Electrical, Implantable, For Incontinence
- Device class
- Class 3
- Medical specialty
- Gastroenterology, Urology
- PMA numbers
- P970004
- Affected lot / code info
- All serial numbers within these catalog/model numbers are affected (Model 3023, Catalog Number 8870MMB01 and 8870NNB01)
Why it was recalled
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).
Root cause (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 800 53rd Ave NE PO Box 1250, Minneapolis, Minnesota 55440-1250
Distribution
- Distribution pattern
- Nationwide and the Netherlands.
Timeline
- Recall initiated
- 2007-06-25
- Posted by FDA
- 2007-10-12
- Terminated
- 2010-10-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #64346. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.