InterStim Micro (neurostimulator)

The main articles are:

• Fecal incontinence
• Urinary incontinence

2020

Medtronic warned of defective neurostimulators

At the end of October 2020, Medtronic issued an urgent notice of InterStim SureScan MRI electrode problems. A special 3560030/3560022 model attachment should be used in conjunction with the electrodes of the InterStim SureScan model 978A1/978B1 scanner and the Verify ENS model 3531 external neurostimulator to further evaluate patients considered candidates for sacral neuromodulation.

The company received 18 reports of electrode-related problems. It turned out that during the evaluation procedure, the connector for percutaneous electrodes spontaneously changed position, migrating from a specially isolated subcutaneous pocket along the tunnel path. These complications, in turn, made it difficult to find and remove the connector and external neurostimulator after the procedure.

Medtronic reported defective neurostimulators

In some cases, an additional cut was required along the tunnel path to disconnect the electrode from the connector. It is suggested that some patients may be at increased risk of procedural complications due to delays associated with addressing this issue. In addition, the company said that in the event of electrode damage or displacement, an intraoperative electrode replacement or additional surgical procedure may be required.

Medtronic included in the notice instructions for suturing around the connector and its body before creating a subcutaneous pocket, and also proposed other measures that could prevent complications from developing. All instructions are provided with detailed diagrams and should limit the excessive mobility of the connector in the subcutaneous pocket during the procedure. If you have questions, Medtronic recommends that doctors contact their local company representative.^[1]

Announcement of InterStim Micro - a miniature neurostimulator from Medtronic

In early August 2020, Medtronic released a new InterStim Micro neurostimulator and the corresponding application for it - InterStim SureScan MRI. The new solutions are designed to treat overactive bladder, fecal incontinence and non-constructive urinary retention.

InterStim Micro is a miniature version of the Medtronic InterStim II neuromodulator, which is only 20% of its older counterpart. However, thanks to Overdrive technology, the battery inside the implant can be recharged to full capacity. At the same time, the service life of InterStim Micro is 15 years. Both the neuromodulator and its applications have been approved for sale in the EU and the US.

Thanks to the SureScan MRI system, which InterStim Micro relies on in its work and which is also compatible with the InterStim II neurostimulator, doctors will be able to prescribe full-body MRI scans to their patients, both on 1.5 T and 3.0 T equipment. If certain preparatory steps are correctly performed, these procedures will be completely safe. Notably, unlike many other MRI devices, InterStim Micro and SureScan applications do not require impedance testing before performing MRI scans.

InterStim Micro Neurostimulator

Using InterStim Micro, patients themselves are responsible for maintaining the implant's charge and can make decisions about where and how to recharge it. Because a full charge takes just under an hour, patients may choose to recharge quickly once a week or longer, but rare.

Urologist of the Minnesota Center for Women's Urology Steve Siegel notes that the new InterStim technology will provide SNM therapy for many more patients, and ideally even allow them to return to normal life.

The new Medtronic technology allows me and my patients to choose the option to recharge the device that best fits their lifestyle.[2]

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