RestoreUltra®SureScan® 97712

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

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

• • 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.

Trade Name

RestoreUltra® SureScan® EUDAMED

RestoreUltra®SureScan® GUDID

Generic Name

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

Device Name

Implantable Neurostimulator

Model / Reference

97712

Primary DI / UDI-DI

00763000100186 EUDAMED

00643169613638 EUDAMED

00763000017149 EUDAMED

00763000270094 EUDAMED

00763000100209 EUDAMED

00643169613621 EUDAMED

00643169613614 EUDAMED

00763000270087 EUDAMED

00643169553125 GUDID

Basic UDI-DI

B-00763000100186, B-00643169613638, B-00763000017149, B-00763000270094, B-00763000100209, B-00643169613621, B-00643169613614, B-00763000270087

PMA Number

P840001 ↗

FDA Product Code

LGW, QRB

EMDN Code

J02020201 Fully implantable spinal neurostimulators, rechargeable

GMDN Term

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

Device Class

Class AIMDD EUDAMED

Class III GUDID

EU market of registration

Netherlands

GUDID distribution status

Not in Commercial Distribution

MRI Safety

MR Conditional

• Concerto Versa™ CVP-15

  Class II

  GUDID on market

• Concerto Versa™ CVP-30

  Class II

  GUDID on market

• Concerto Versa™ CVP-40

  Class II

  GUDID on market

• Concerto Versa™ CVP-65

  Class II

  GUDID on market

• Pacific™ Plus

  Class IIa

  CE/MDR

• Vanta™ AdaptiveStim™

  Class III

  CE/MDR G70 039709 1363 Active Valid to Sep 2031

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