VNS Therapy® Programmer, Model 3000 v1.6.2

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• 2 recalls, same reason

  • Ongoing Z-1067-2025 FDA Class II ·initiated 3 Jan 2025
  • Ongoing Z-1068-2025 FDA Class II ·initiated 3 Jan 2025

  Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.

• • Ongoing Z-1072-2025 FDA Class II ·initiated 12 Dec 2024

  Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.

• • Ongoing Z-1563-2020 FDA Class II ·initiated 4 Feb 2020

  False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.

• • Ongoing Z-0663-2020 FDA Class II ·initiated 16 Nov 2018

  This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.

• • Ongoing Z-0346-2020 FDA Class II ·initiated 16 Nov 2018

  Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS generator takes the lead impedance measurement during diagnostic testing. As a result, normal impedance ranges for the affected VNS generator have shifted relative to the existing thresholds of 600 - 5300 Ohms defined in labeling and as present in the programming software.

• • Terminated Z-0532-2022 FDA Class II ·initiated 2 Dec 2021

  A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience discomfort or pain due to delivery of stimulation to an unintended location. If the inner lead conductor is exposed to body fluids the lead may break causing loss of therapy.

• • Terminated Z-0462-2021 FDA Class II ·initiated 28 Sep 2020

  Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.

• • Terminated Z-0561-2020 FDA Class I ·initiated 22 Aug 2019

  Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation.

• • Terminated Z-1118-2020 FDA Class II ·initiated 13 Aug 2019

  Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.

• 2 recalls, same reason

  • Terminated Z-0869-2020 FDA Class II ·initiated 16 Nov 2018
  • Terminated Z-0868-2020 FDA Class II ·initiated 16 Nov 2018

  This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018.

• • Terminated Z-2572-2018 FDA Class II ·initiated 24 Jan 2018

  Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.

• • Terminated Z-0555-2018 FDA Class II ·initiated 2 Dec 2017

  Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.

• • Terminated Z-2255-2018 FDA Class II ·initiated 13 Nov 2017

  Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects (Model 106 only); " No stimulation in the case of device disablement (Burst Watchdog Timeout), resulting in no therapy to the patient (Model 106 only); " Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved within device specification (Models 103, 104, 105, or 106); and/or " Delays or absence of the 75% and 50% battery life indicators displayed by the programming software (Models 103, 104, 105, or 106).

• • Terminated Z-0659-2016 FDA Class II ·initiated 18 Dec 2015

  Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.

• • Terminated Z-0645-2016 FDA Class II ·initiated 18 Nov 2015

  Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.

• • Terminated Z-0280-2016 FDA Class II ·initiated 7 Oct 2015

  Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity.

• • Terminated Z-0858-2015 FDA Class II ·initiated 20 Nov 2014

  The recalled product was distributed with an incorrect serial number printed on the device's label.

• • Terminated Z-0210-2012 FDA Unclassified (pre-2012) ·initiated 12 Aug 2011

  The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation.

• 2 recalls, same reason

  • Terminated Z-0006-2012 FDA Unclassified (pre-2012) ·initiated 6 May 2011
  • Terminated Z-0005-2012 FDA Unclassified (pre-2012) ·initiated 6 May 2011

  An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator (IFI) message was unexpectedly received by a medical professional when using Model 250 version 8.0 software to interrogate a patient's Model 103 Generator.

• • Terminated Z-1591-2010 FDA Unclassified (pre-2012) ·initiated 6 Apr 2010

  Battery life projection is inaccurate.

• • Terminated Z-0994-2009 FDA Unclassified (pre-2012) ·initiated 7 Feb 2008

  Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference resulting in the loss of stimulation.

• • Terminated Z-0995-2009 FDA Unclassified (pre-2012) ·initiated 7 Feb 2008

  Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference, resulting in the loss of stimulation.

• 3 recalls, same reason

  • Terminated Z-0173-2008 FDA Unclassified (pre-2012) ·initiated 2 Aug 2007
  • Terminated Z-0172-2008 FDA Unclassified (pre-2012) ·initiated 2 Aug 2007
  • Terminated Z-0171-2008 FDA Unclassified (pre-2012) ·initiated 2 Aug 2007

  Dissolution/Fractures to the leads of the VNS Therapy System

• 2 recalls, same reason

  • Terminated Z-0341-2007 FDA Unclassified (pre-2012) ·initiated 17 Oct 2006
  • Terminated Z-0342-2007 FDA Unclassified (pre-2012) ·initiated 17 Oct 2006

  During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician

Trade Name

VNS Therapy® EUDAMED

VNS Therapy® Programmer, Model 3000 v1.6.2 GUDID

VNS Therapy® Programmer, Model 3000 v1.6 GUDID

Generic Name

Vagus nerve electrical stimulation system programmer

Device Name

VNS Therapy® Programmer

Model / Reference

Model 3000v1.6.2 EUDAMED

3000v1.6.2 EUDAMED

Model 3000v1.6.1 EUDAMED

3000v1.6.1 EUDAMED

3000 GUDID

Primary DI / UDI-DI

05425025750535, 05425025750443

Basic UDI-DI

B-05425025750535, B-05425025750443

PMA Number

P970003 ↗

FDA Product Code

LYJ, MUZ

EMDN Code

J020701 Neurostimulators programmers

GMDN Term

Vagus nerve electrical stimulation system programmer

Device Class

Class AIMDD EUDAMED

Class III GUDID

Special Device Type

-1200

Market of Registration

Italy

Commercial Distribution

In Commercial Distribution

MRI Safety

MR Unsafe

• Perfusion Pack

  Class II

  GUDID on market

• Perfusion Pack

  Class II

  GUDID on market

• Perfusion Pack

  Class II

  GUDID on market

• Perfusion Pack

  Class II

  GUDID on market

• Perfusion Pack

  Class II

  GUDID on market

• Perfusion Pack

  Class II

  GUDID on market

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