Na 1291

• • Ongoing Z-0458-2026 FDA Class II ·initiated 6 Oct 2025

  There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).

• 7 recalls, same reason

  • Ongoing Z-2508-2023 FDA Class I ·initiated 18 Jul 2023
  • Ongoing Z-2511-2023 FDA Class I ·initiated 18 Jul 2023
  • Ongoing Z-2509-2023 FDA Class I ·initiated 18 Jul 2023
  • Ongoing Z-2510-2023 FDA Class I ·initiated 18 Jul 2023
  • Ongoing Z-2507-2023 FDA Class I ·initiated 18 Jul 2023
  • Ongoing Z-2505-2023 FDA Class I ·initiated 18 Jul 2023
  • Ongoing Z-2506-2023 FDA Class I ·initiated 18 Jul 2023

  Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

• 2 recalls, same reason

  • Terminated Z-2692-2017 FDA Class II ·initiated 2 Jun 2017
  • Terminated Z-2691-2017 FDA Class II ·initiated 2 Jun 2017

  The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.

• • Terminated Z-1785-2013 FDA Class II ·initiated 30 Nov 2012

  There is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs). In the July 2012 letter St. Jude Medical informed customers that they would be implementing design improvements to the charger to address possible increased energy dissipation when the charger is misaligned with the IPG or the IPG is implanted too near the surface of the

• • Terminated Z-0025-2013 FDA Class II ·initiated 4 Sep 2012

  Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board.

• • Terminated Z-1738-2013 FDA Class II ·initiated 26 Jul 2012

  St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medica

• • Terminated Z-3091-2011 FDA Unclassified (pre-2012) ·initiated 2 Jun 2009

  Product programmed with unapproved software was distributed.

Generic Name

Pin-indexed adaptor, reusable

Model / Ref / Catalog

1291

Primary DI / UDI-DI

05414734401005

PMA Number

P010032 ↗

FDA Product Code

LGW

GMDN Term

Pin-indexed adaptor, reusable

Device Class

Class III

GUDID distribution status

In Commercial Distribution

Category: Pin-indexed adaptor, reusable

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