Medtronic safety notice: 15 cases of InterStim leads or extensions mismatched with the planned device type

Medtronic/InterStim sacral neuromodulation (Micro / X)

Medtronic sent surgeons a safety notice, published by France's medicines agency ANSM, reminding them to check that InterStim leads and extensions match the rechargeable or recharge-free system planned. It had received 15 complaints since 2020 where a mismatched part stopped the system working, in some cases delaying surgery or forcing a replacement. Medtronic said no product defect was found.

• Covers SureScan MRI leads 978A1 and 978B1 and percutaneous extensions 3560022 and 3560030.
• 15 complaints between 1 January 2020 and 12 August 2026, a worldwide rate of 0.006%.
• Surgeons are asked to verify model compatibility and run a system integrity check before implanting.