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TH91DBS

by Medtronic, Inc.

Part of a family of 62 devices: see the family page

Ref TH91DBS

TH91DBS is a Class III device made by Medtronic, Inc., registered in EUDAMED on 21 Jul 2026 (Basic UDI-DI 0763000B000100773), approved under FDA PMA P960009 on 31 Jul 1997 and listed in FDA GUDID since 22 Jan 2024 (UDI-DI 00763000813871), active as of 23 Oct 2026. 19 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

8 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

PMA P960009

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000100773 Basic UDI-DI 00763000813871UDI-DIDate21 Jul 2026RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number00763000813871 UDI-DI Date22 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP960009 Date31 Jul 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000100773 registered 21 Jul 2026 Active
  • FDA PMA P960009 decided 31 Jul 1997 Active
  • FDA GUDID UDI-DI 00763000813871 listed 22 Jan 2024 Listed

Recalls

20 recalls · 8 ongoing · FDA

  • 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.

Timeline

23 dated events

  1. Recall initiated FDA recalls Z-0201-2022
  2. Recall initiated FDA recalls Z-0418-2022
  3. Recall initiated FDA recalls Z-1128-2022
  4. Recall initiated FDA recalls Z-0217-2024
  5. Listed FDA GUDID 00763000813871
  6. Recall initiated FDA recalls Z-0372-2025
  7. Recall initiated FDA recalls Z-0206-2025
  8. Recall initiated FDA recalls Z-2240-2026
  9. Recall initiated FDA recalls Z-2241-2026
  10. Registered EUDAMED 0763000B000100773

13 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Generic name
Multiple active implantable device programmer
Device name
Handset with Communicator
Model / reference
TH91DBS
Primary DI / UDI-DI
00763000813871 EUDAMED
00763000640033 GUDID
Basic UDI-DI
0763000B000100773
PMA number
FDA product code
MBX, NHL, MHY, PJS, SGS, OLM
EMDN code
J020780 Neurostimulators programmers - hardware accessories
GMDN term
Multiple active implantable device programmer
Device class
Class III
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
Процедурният пакет доставя компонентите, необходими за комуникация с имплантируемо медицинско изделие – мобилно устройство заедно с комуникатор и свързаните етикети.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00763000813871
GUDID
00763000640033

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00763000813871; FDA GUDID lists 00763000640033), so their flags are not compared.

Related devices

Category: Multiple active implantable device programmer

Cleared under the same submission (P960009)

and 8 more cleared under P960009

Similar devices in this category

Other devices filed under NEUROSTIMULATORS PROGRAMMERS AND ACCESSORIES.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Serial number
Other properties (12, all answered No)