Advice
Regulatory information
Regulatory information
Differential target multiplexed spinal cord stimulation (DTM SCS) therapy is delivered using Medtronic's Intellis platform. The Intellis system is a CE marked Class III medical device.
The following manufacturer field safety notices or medical device alerts for this technology have been identified:
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Medicines and Healthcare products Regulatory Agency Field Safety Notice for Intellis (2020/012/018/291/008). This alert was for the Intellis Software Application version 1.3.80 that could not reset invalid memory correctly. The users were requested to update to version 1.3.130.
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Medicines and Healthcare products Regulatory Agency Field Safety Notice for the Intellis recharger (2021/003/026/487/007). This alert was for the potential unintended heating of the Intellis Model 97755 Recharger. Clinicians were requested to reinforce care and maintenance guidelines with all users, who were also requested to contact their Medtronic representative if their recharger was visibly damaged.