SenSight™ B31000

• EUDAMED Basic UDI-DI 0763000B00024568B registered 15 Sep 2026 Active· +1 more in the status table
• FDA PMA P960009 decided 31 Jul 1997 Active
• FDA HDE H020007 Active
• FDA GUDID UDI-DI 00763000970697 listed 5 Jun 2021 Listed

• 2 recalls, same reason

  • Ongoing Z-2240-2026 FDA Class II ·initiated 13 May 2026
  • Ongoing Z-2241-2026 FDA Class II ·initiated 13 May 2026

  A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

• • Ongoing Z-0206-2025 FDA Class II ·initiated 24 Sep 2024

  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" message will appear.

• • Ongoing Z-0372-2025 FDA Class II ·initiated 18 Sep 2024 ·on shared PMA P960009

  The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.

• • Ongoing Z-1128-2022 FDA Class II ·initiated 30 Mar 2022

  The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

• • Ongoing Z-0418-2022 FDA Class II ·initiated 19 Oct 2021

  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 an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.

• • Ongoing Z-0201-2022 FDA Class II ·initiated 23 Sep 2021

  A software anomaly may occur with the clinician programmer application.

• • Ongoing Z-1368-2021 FDA Class II ·initiated 9 Mar 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 "replacement" function of the A610 clinician programmer application, the cycling feature is not copied properly. 2. Log Fill Issue: When the Percept PC INS System Event log is full, the clinician programmer A610 Software application version 2.0.4584, 2.0.4594, 2.0.4605, or 3.0.1057 crashes when it attempts a reading of the last records in the log.

• • Completed Z-0217-2024 FDA Class II ·initiated 27 May 2022

  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 individual product label.

• • Terminated Z-3069-2017 FDA Class II ·initiated 17 Mar 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.

• • Terminated Z-2645-2016 FDA Class II ·initiated 23 Jun 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 device specific labeling for the handling of pocket adaptors and system integrity checking during implant procedures.

• • Terminated Z-2602-2016 FDA Class II ·initiated 10 Jun 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 identified the potential for lead insulation damage.

• • Terminated Z-1617-2015 FDA Class II ·initiated 16 Apr 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 can be used with the following implantable Neurostimulators: Activa PC (Model 37601), Activa RC (Model 37612), and the Activa SC (Model 37603).

• • Terminated Z-0279-2014 FDA Class II ·initiated 30 Sep 2013

  Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).

• • Terminated Z-1190-2013 FDA Class I ·initiated 8 Feb 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 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

• 4 recalls, same reason

  • Terminated Z-0184-2009 FDA Unclassified (pre-2012) ·initiated 14 Jun 2008
  • Terminated Z-0187-2009 FDA Unclassified (pre-2012) ·initiated 14 Jun 2008
  • Terminated Z-0186-2009 FDA Unclassified (pre-2012) ·initiated 14 Jun 2008
  • Terminated Z-0185-2009 FDA Unclassified (pre-2012) ·initiated 14 Jun 2008

  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 torsion and / or tensile lading of the proximal connector end of the lead. Data also suggest that excessive torque while tightening or loosening the setscrews may twist the setscrew connector block and d

• • Terminated Z-0370-06 FDA Unclassified (pre-2012) ·initiated 30 Nov 2005

  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 use of a displayed MRI head specific absorption rate (SAR) of not more than 0.4 W/kg. The recommended maximum displayed head SAR is now 0.1 W/kg.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 19 Oct 2021 Recall initiated FDA recalls Z-0418-2022
2. 30 Mar 2022 Recall initiated FDA recalls Z-1128-2022
3. 27 May 2022 Recall initiated FDA recalls Z-0217-2024
4. 18 Sep 2024 Recall initiated FDA recalls Z-0372-2025
5. 24 Sep 2024 Recall initiated FDA recalls Z-0206-2025
6. 13 May 2026 Recall initiated FDA recalls Z-2240-2026
7. 13 May 2026 Recall initiated FDA recalls Z-2241-2026
8. 10 Aug 2026 Certificate issued EUDAMED G70 039709 1513
9. 15 Sep 2026 Registered EUDAMED 0763000B00024568B
10. 16 Dec 2029 Certificate expires EUDAMED G70 039709 1513

15 earlier events are in the sections above.

Trade name

SenSight™

Generic name

Craniofacial fixation plate, non-bioabsorbable, non-customized

Device name

SenSight™ Burr Hole Device

Model / reference

B31000

Primary DI / UDI-DI

00763000970697 EUDAMED

00763000949624 EUDAMED

00763000426514 GUDID

Basic UDI-DI

0763000B00024568B

PMA number

H020007 ↗

P960009 ↗

FDA product code

MBX, PJS, MRU, NHL, MHY

EMDN code

J020180 Cerebral implantable neurostimulators - accessories

GMDN term

Craniofacial fixation plate, non-bioabsorbable, non-customized

Device class

Class III

EU registration type

Standard device

EU market of registration

Netherlands

GUDID distribution status

In Commercial Distribution

MRI safety

MR Conditional

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00763000970697, 00763000949624; FDA GUDID lists 00763000426514), so their flags are not compared.

Category: Craniofacial fixation plate, non-bioabsorbable, non-customized

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