Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_0
FDA device recall Z-0040-2008 · posted 2007-10-12 · Terminated
Recall details
- Recalling firm
- Medtronic Neuromodulation
- 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).
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- EZW
- Quantity affected
- 1885
- Distribution
- Nationwide and the Netherlands.
- Date initiated
- 2007-06-25
- Date posted
- 2007-10-12
- Date terminated
- 2010-10-08
- Location
- Minneapolis, MN
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