# P960009: Medtronic Activa Tremor Control System

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Jul 31, 1997 after 456 days
- Product code: MHY (Stimulator, Electrical, Implanted, For Parkinsonian Tremor)
- Device class: 3
- Recalls of this device: 20 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- May 13, 2026 · Class II · Z-2240-2026: A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
- May 13, 2026 · Class II · Z-2241-2026: A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
- Sep 24, 2024 · Class II · Z-0206-2025: A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" mess
- Sep 18, 2024 · Class II · Z-0372-2025: The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
- May 27, 2022 · Class II · Z-0217-2024: There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the indivi
- Mar 30, 2022 · Class II · Z-1128-2022: The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
- Oct 19, 2021 · Class II · Z-0418-2022: During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct a
- Sep 23, 2021 · Class II · Z-0201-2022: A software anomaly may occur with the clinician programmer application.
- Mar 9, 2021 · Class II · Z-1368-2021: There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using the "replac
- Mar 17, 2017 · Class II · Z-3069-2017: Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in DBS lead placement beyond the intended target.
- Jun 23, 2016 · Class II · Z-2645-2016: Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001 and Model 64002, a safety notification was sent to healthcare professionals to reinforce devic
- Jun 10, 2016 · Class II · Z-2602-2016: Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. During the manufacturing process of a DBS lead component, Medtronic ide
- Apr 16, 2015 · Class II · Z-1617-2015: Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which ca
- Sep 30, 2013 · Class II · Z-0279-2014: Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creatin
- Feb 8, 2013 · Class I · Z-1190-2013: 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 t
- Jun 14, 2008 · Not classified · Z-0187-2009: Medtronic has received reports of DBS" leads being damaged at the proximal connector end of the lead when the lead cap is used in the implant procedure. The lead damage is the result of excessive tors
- Jun 14, 2008 · Not classified · Z-0184-2009: Medtronic has received reports of DBS" leads being damaged at the proximal connector end of the lead when the lead cap is used in the implant procedure. The lead damage is the result of excessive tors
- Jun 14, 2008 · Not classified · Z-0186-2009: Medtronic has received reports of DBS" leads being damaged at the proximal connector end of the lead when the lead cap is used in the implant procedure. The lead damage is the result of excessive tors
- Jun 14, 2008 · Not classified · Z-0185-2009: Medtronic has received reports of DBS" leads being damaged at the proximal connector end of the lead when the lead cap is used in the implant procedure. The lead damage is the result of excessive tors
- Nov 30, 2005 · Not classified · Z-0370-06: A safety concern exists regarding the Medtronic Activa Deep Brain Stimulation system instructions for performing MRI (magnetic resonance imaging). Medtronic's instructions have until now recommended a

Source page: https://510kreport.com/device/P960009
Methodology: https://510kreport.com/methodology