Spectra WaveWriter™ SC-5160

• EUDAMED Basic UDI-DI B-08714729952046 registered 5 Nov 2026 Active
• FDA PMA P030017 decided 27 Apr 2004 Active
• FDA GUDID UDI-DI 08714729952046 listed 5 Jun 2017 Listed

• • Ongoing Z-2879-2026 FDA Class I ·initiated 17 Jun 2026

  Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.

• • Ongoing Z-2404-2026 FDA Class II ·initiated 29 Apr 2026

  Sterile anchors my lack sterility assurance.

• • Ongoing Z-2617-2024 FDA Class II ·initiated 17 Jul 2024

  Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.

• 5 recalls, same reason

  • Terminated Z-2124-2020 FDA Class II ·initiated 24 Apr 2019
  • Terminated Z-2122-2020 FDA Class II ·initiated 24 Apr 2019
  • Terminated Z-2119-2020 FDA Class II ·initiated 24 Apr 2019
  • Terminated Z-2121-2020 FDA Class II ·initiated 24 Apr 2019
  • Terminated Z-2120-2020 FDA Class II ·initiated 24 Apr 2019

  The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.

• • Terminated Z-2123-2020 FDA Class II ·initiated 24 Apr 2019

  The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.

• • Terminated Z-1409-2010 FDA Unclassified (pre-2012) ·initiated 19 Mar 2010

  Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers. Based on Toshiba's investigation with Sony Corporation, they concluded that the battery cells in specific manufacturing lots could be affected.

• • Terminated Z-0271-2009 FDA Unclassified (pre-2012) ·initiated 22 Sep 2008

  Since April 2004, 27 of 8,769 (0.31%) patients have reported receiving second degree burns in the area of charging and 3 of 8,769 (0.03%) patients have reported receiving third degree burns in the area of charging while using Charger 1 .0. Some of these events were the direct result of the patient disregarding the instructions for use, such as sleeping with the Charger on or placing it directly on

• • Terminated Z-1441-2012 FDA Unclassified (pre-2012) ·initiated 22 Apr 2008

  The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual.

• • Terminated Z-0960-2008 FDA Unclassified (pre-2012) ·initiated 5 Oct 2007

  Incorrect Data -- Corruption of internal memory component results in an inability for the physician to reprogram the IPG with firmware version prior to Revision 3.02. When this occurs, the IPG will report an error code of "10h0" or "00h0" through the Remote Control. Under this condition, the IPG will cease to log in some data that could be used for informational purposes. ** It should be noted t

• • Terminated Z-0055-2008 FDA Unclassified (pre-2012) ·initiated 3 Aug 2007

  Mislabeled: Product labeled with the incorrect shelf-life information.

• • Terminated Z-0700-2007 FDA Unclassified (pre-2012) ·initiated 30 Jan 2007

  The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.

• • Terminated Z-0299-2007 FDA Unclassified (pre-2012) ·initiated 21 Sep 2006

  A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient.

• • Terminated Z-0396-05 FDA Unclassified (pre-2012) ·initiated 11 Nov 2004

  A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.

1. 24 Apr 2019 Recall initiated FDA recalls Z-2124-2020
2. 24 Apr 2019 Recall initiated FDA recalls Z-2122-2020
3. 24 Apr 2019 Recall initiated FDA recalls Z-2119-2020
4. 24 Apr 2019 Recall initiated FDA recalls Z-2123-2020
5. 24 Apr 2019 Recall initiated FDA recalls Z-2121-2020
6. 24 Apr 2019 Recall initiated FDA recalls Z-2120-2020
7. 17 Jul 2024 Recall initiated FDA recalls Z-2617-2024
8. 29 Apr 2026 Recall initiated FDA recalls Z-2404-2026
9. 17 Jun 2026 Recall initiated FDA recalls Z-2879-2026
10. 5 Nov 2026 Registered EUDAMED B-08714729952046

10 earlier events are in the sections above.

Trade name

Spectra WaveWriter™

Generic name

Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

Device name

ETS Accessories

Model / reference

M365SC51600 EUDAMED

SC-5160 GUDID

Primary DI / UDI-DI

08714729952046

Basic UDI-DI

B-08714729952046

PMA number

P030017 ↗

FDA product code

LGW, QRB

EMDN code

J0299 Implantable neurostimulators - other

GMDN term

Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

Device class

Class AIMDD EUDAMED

Class III GUDID

EU registration type

Legacy device (under a directive)

EU market of registration

Netherlands

GUDID distribution status

In Commercial Distribution

Device class is stated on each registry's own scale: Class AIMDD in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Category: Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

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• SCS Freedom-8A Permanent Neurostimulator Receiver Kit Channel A FR8A-RCV-A0 by Curonix LLC

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