Implanted Subcortical Electrical Stimulator (Motor Disorders)
FDA adverse event reports and recall history for implanted subcortical electrical stimulator (motor disorders) (product code MRU), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,888
- Deaths
- 16
- Injuries
- 1,318
- Malfunctions
- 1,553
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2013-05-01TerminatedProcess control
Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis).
There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damag
- Open, ClassifiedUnder Investigation by firm
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Monitor implanted subcortical electrical stimulator (motor disorders) automatically
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