Safety Alert Or Field Safety Notices for N’Vision® and InterStim iCon® used with InterStim implantable neurostimulator model 3023 for pelvic floor disorders neurostimulator programmers

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

An error in the programmer software (revision NNB_01) may lead to false warnings of a low battery status. There is a risk that pre-existing symptoms may return if the device ceases to function when true low or end of service battery warnings are subsequently ignored.There are three ways to measure battery status in the model 3023 InterStim neurostimulator:using the InterStim iCon patient programmer
Automated Measurement feature on N’Vision clinician programmer
Therapy Measurement feature on N’Vision clinician programmer.Medtronic has identified that only the Therapy Measurement feature on the N’Vision programmer is accurate. It is therefore important to interpret all other low battery warnings with caution.In July 2007 Medtronic issued a Field Safety Notice (FSN) to alert users to the potential for false low battery warnings on the clinician and patient programmers and to advise of an accurate way to assess the battery capacity on the clinician programmer (see Appendix). Clinicians were advised that patients experiencing a low battery warning on their programmer (which were subsequently confirmed as false in clinic) should ignore further low battery warnings. The FSN also advised that new software was in development for both clinician and patient programmers to address the issue.In July 2008 Medtronic advised the MHRA that the software upgrade was in the approval process and would not be available for implementation for a further few months.It is possible that some model 3023 InterStim devices are now nearing the end of their life, and so genuine low battery alerts may be ignored (although it should be noted that the end of service (EOS) battery alert on the iCon programmer is valid). This could lead to a device ceasing to function before it can be replaced, and a return of the patient’s pre-existing symptoms.