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Terminated

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 Recall Z-0040-2008 · Posted 2007-10-12

Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeEZW
Date Initiated2007-06-25
Date Terminated2010-10-08
Product Quantity1885

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).

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide and the Netherlands.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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