Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Recall Z-0037-2008 · Posted 2007-10-11

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

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 .

Firm 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.

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.

↑