TriCentrus™ 3292Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 05415067047823), received between Apr 29, 2024 and Sep 30, 2026 — classified as 127 injuries.

The most frequently reported specific device problem is “Migration” (27 reports).

14 other recalls cover devices cleared under the same FDA submission (P010032); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced an infection at the IPG and lead sites and was hospitalized. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the entire system was explanted to address the issue. The patient was administered antibiotics to address the issue.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50951765 ↗
• InjurySep 29, 2026Therapeutic or Diagnostic Output Failure

  It was reported the patient experienced ineffective stimulation. Surgical intervention took place wherein the system was explanted to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50931836 ↗
• InjurySep 28, 2026Therapeutic or Diagnostic Output Failure

  It was reported that the patient experienced ineffective therapy. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the system was explanted to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50923252 ↗
• InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Numbness

  MAUDE report 50909968 ↗
• InjurySep 25, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient experienced a tingling sensation despite therapy being turned off. To address the reported issue, the system was explanted.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50896789 ↗
• InjurySep 20, 2026Migration

  Patient problems: Inadequate Pain Relief

  MAUDE report 50834811 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a Cerebrospinal Fluid (CSF) accumulation due to intradural placement. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the system was explanted to address the issue.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 50803090 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Post Operative Wound Infection

  MAUDE report 50796464 ↗
• InjurySep 16, 2026Fracture

  It was reported that the patient experienced ineffective therapy. X-ray imaging revealed fracture of the lead. As a result, surgical intervention was undertaken on(b)(6) 2026 wherein the lead was explanted and replaced to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50791623 ↗
• InjuryAug 21, 2026Therapeutic or Diagnostic Output Failure

  It was reported that the patient experienced ineffective therapy. Reprogramming was unable to resolve the issue. As such, surgical intervention took place wherein the entire system was explanted to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50381054 ↗
• InjuryJul 31, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient experienced uncomfortable stimulation, and migration of the IPG. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 50107755 ↗
• InjuryJul 27, 2026Migration

  It was reported the patient experienced ineffective stimulation due to the lead migrating. X-rays confirmed the migration. Surgical intervention may take place at a later date.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50015834 ↗
• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE LEAD IMPLANT SITE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE PADDLE LEAD WAS EXPLANTED AND REPLACED WITH PERCUTANEOUS LEADS TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 25654004 ↗
• InjuryJun 27, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY AFTER IMPLANT. X-RAY IMAGING REVEALED MIGRATION OF BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 TO ADDRESS THE ISSUE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25646238 ↗
• InjuryJun 25, 2026Migration

  IT WAS REPORTED PATIENT'S CERVICAL LEAD HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25628838 ↗
• InjuryJun 15, 2026Migration

  IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE THERAPY DUE TO LEAD MIGRATION. THIS WAS CONFIRMED VIA X-RAY. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25513406 ↗
• InjuryJun 9, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO INCREASE THEIR THERAPY STRENGTH. IMPEDANCE CHECK REVEALED HIGH IMPEDANCES ON ALL CONTACTS OF THE LEAD. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS CONFIRMED POST OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25449478 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NUMBNESS IN THEIR RIGHT ARM AND LEG. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Numbness

  MAUDE report 25354304 ↗
• InjuryMay 27, 2026Migration

  IT WAS REPORTED THAT AFTER A FALL, THE PATIENT LOST THERAPY DUE TO LEAD MIGRATION. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE LEAD WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-SURGERY.

  Patient problems: Inadequate Pain Relief; Undesired Nerve Stimulation

  MAUDE report 25304205 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DISCHARGE AT THE LEAD INCISION SITE. ON (B)(6) 2026, THE SURGEON CLOSED THE SITE TO ADDRESS THE ISSUE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS TO ADDRESS THE ISSUE. NO INFECTION WAS SUSPECTED. PATIENT IS HEALING WELL.

  Patient problems: Fluid Discharge

  MAUDE report 25161782 ↗
• InjuryMay 11, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION AND THE LEAD EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25141663 ↗
• InjuryMay 8, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE THE LEAD WAS REPLACED TO EXPAND COVERAGE RANGE AND ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25124776 ↗
• InjuryMay 7, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION AND THE LEAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25108624 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHILLS AND DRAINAGE AT THE LEAD INCISION SITE. AS SUCH, THE PATIENT WAS PUT ON ANTIBIOTICS TO ADDRESS THE ISSUE AND A WOUND CHECK WAS PERFORMED BY THE DOCTOR. REPORTEDLY, THE INCISIONS LOOKED FINE.

  Patient problems: Chills; Fluid Discharge; Post Operative Wound Infection

  MAUDE report 24944957 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OPEN WOUND, SUSPECTED INFECTION, AND DRAINAGE AT THE IPG AND LEAD SITE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Fluid Discharge; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 24866192 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010032. One submission often covers many models, so check the product and lot details in each record.

• Z-0458-2026 · Oct 6, 2025 · Open, Classified
  Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
• Z-2509-2023 · Jul 18, 2023 · Open, Classified
  Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extens
• Z-2511-2023 · Jul 18, 2023 · Open, Classified
  Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio
• Z-2505-2023 · Jul 18, 2023 · Open, Classified
  Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electr
• Z-2510-2023 · Jul 18, 2023 · Open, Classified
  Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio
• Z-2506-2023 · Jul 18, 2023 · Open, Classified
  Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device
• Z-2507-2023 · Jul 18, 2023 · Open, Classified
  Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext
• Z-2508-2023 · Jul 18, 2023 · Open, Classified
  Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext
• Z-2692-2017 · Jun 2, 2017 · Terminated
  Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be c
• Z-2691-2017 · Jun 2, 2017 · Terminated
  Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be c
• Z-1785-2013 · Nov 30, 2012 · Terminated
  Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 reca
• Z-0025-2013 · Sep 4, 2012 · Terminated
  The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode
• Z-1738-2013 · Jul 26, 2012 · Terminated
  Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or li
• Z-3091-2011 · Jun 2, 2009 · Terminated
  Software version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting im