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A71400

by Medtronic, Inc.

Ref A71400

A71400 is a Class III device made by Medtronic, Inc., registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 0763000B00008798V) with CE/MDR certificate G70 039709 1443 valid until 13 Aug 2028, approved under FDA PMA P840001 on 30 Nov 1984 and listed in FDA GUDID since 5 May 2024 (UDI-DI 00763000371463), active as of 25 Oct 2026. 9 FDA recalls are linked to it.

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

CE MDR PMA

Valid until

13 Aug 2028

CE MDR certificate

FDA recalls

4 ongoing

This device is named in the recall

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

PMA P840001

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00008798V Basic UDI-DI 00763000371463UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000371463 UDI-DI Date5 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP840001 Date30 Nov 1984DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00008798V registered 23 Jul 2026 Active· +1 more in the status table
  • FDA PMA P840001 decided 30 Nov 1984 Active
  • FDA GUDID UDI-DI 00763000371463 listed 5 May 2024 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 039709 1443 Active Supplemented

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    15 Jun 2026
    Expires
    13 Aug 2028
    Reason
    Change approved

Recalls

9 recalls · 4 ongoing · FDA

    • Ongoing Z-0372-2025 FDA Class II initiated 18 Sep 2024

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

    • Ongoing Z-1691-2024 FDA Class II initiated 28 Mar 2024

    inability to reprogram one device

    • Ongoing Z-0780-2024 FDA Class II initiated 19 Dec 2023

    Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.

    • Ongoing Z-2159-2021 FDA Class II initiated 9 Jul 2021

    Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.

    • Terminated Z-1926-2016 FDA Class II initiated 3 May 2016

    Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior to obtaining recharge threshold voltage of 3.615, which triggered rapid battery depletion state. As a result, the device depleted to 1.925 volts in one to two days rather than the typical 30 days. Insufficient coupling between recharger and device during recharge session was found to be key factor.

    • Terminated Z-1147-2015 FDA Class II initiated 9 Jan 2015

    Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, longevity estimate displayed on the Model 8840Programmer may be inaccurate.

    • Terminated Z-1524-2014 FDA Class II initiated 27 Feb 2014

    Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval

    • Terminated Z-0278-2014 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-1536-06 FDA Unclassified (pre-2012) initiated 2 Aug 2006

    Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead kits labeled 3777 lot V009545 may contain a 3778 compact-spaced lead, while those labeled 3778 lot V009546 may contain a 3777 standard-spaced lead. The result of this error is an overall increase or decrease of 14 mm in the electrode coverage.

Timeline

14 dated events

  1. Recall initiated FDA recalls Z-1147-2015
  2. Recall initiated FDA recalls Z-1926-2016
  3. Recall initiated FDA recalls Z-2159-2021
  4. Recall initiated FDA recalls Z-0780-2024
  5. Recall initiated FDA recalls Z-1691-2024
  6. Listed FDA GUDID 00763000371463
  7. Recall initiated FDA recalls Z-0372-2025
  8. Certificate issued EUDAMED G70 039709 1443
  9. Registered EUDAMED 0763000B00008798V
  10. Certificate expires EUDAMED G70 039709 1443

4 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
Stimulation RC Clinician Programmer App
Model / reference
A71400
Primary DI / UDI-DI
00763000371463
Basic UDI-DI
0763000B00008798V
PMA number
FDA product code
LGW, QRB
EMDN code
J020782 Neurostimulators programmers - software accessories
GMDN term
Multiple active implantable device programmer
Device class
Class III
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple active implantable device programmer

Cleared under the same submission (P840001)

and 8 more cleared under P840001

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
  • Lot / batch number
Other properties (23, all answered No)