Recalls / —
—#53499
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.
- 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 3058, Catalog # 8870MM01 & 8870NNB01
Why it was recalled
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 .
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 mangement of 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
- 2007-10-11
- Terminated
- 2010-10-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #53499. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.