Penta™ 3228 (UDI 05414734401913)Recalls & reported problems

Summary

The FDA's MAUDE database contains 489 adverse event reports that list this exact device (DI 05414734401913), received between Jun 25, 2018 and Sep 22, 2026 — classified as 488 injuries, 1 malfunction.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (154 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 489 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: Inadequate Pain Relief

  MAUDE report 50860946 ↗
• InjurySep 18, 2026High impedance

  It was reported that the patient experienced ineffective therapy due to high impedances. As such, surgical intervention may take place at a later date to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50820445 ↗
• InjuryJul 8, 2026Fracture

  IT WAS REPORTED DURING IPG REPLACEMENT PROCEDURE, THE PHYSICIAN VISUALLY SAW THE LEAD WAS FRACTURED BUT PATIENT WAS GETTING EFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION MAY OCCUR IN THE FUTURE TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25743273 ↗
• InjuryJun 24, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHERE THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25608533 ↗
• InjuryJun 17, 2026Migration

  IT WAS REPORTED THAT DURING AN IPG REPLACEMENT [RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2026-02354], THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY DUE TO LEAD MIGRATION, CONFIRMED BY X-RAY. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED DURING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25532315 ↗
• InjuryMay 16, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING SENSATIONS. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 25195228 ↗
• InjuryMay 4, 2026Fracture

  IT WAS REPORTED THAT PATIENTS LEAD WAS FRACTURED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25071792 ↗
• InjuryApr 15, 2026High impedance

  ADDITIONAL INFORMATION INDICATES THAT THE PATIENT IS HAVING EFFECTIVE THERAPY AND NO LONGER NEED ANY SURGICAL INTERVENTION; THEREFORE, THIS EVENT IS NO LONGER CONSIDERED TO BE REPORTABLE.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885630 ↗
• InjuryApr 14, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING AN IPG EXPLANT PROCEDURE ON (B)(6) 2026, THE PHYSICIAN CUT THE LEAD, LEAVING IT IMPLANTED. PER THE PATIENT¿S REQUEST, NO SURGICAL INTERVENTION WILL BE PERFORMED TO ADDRESS THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24876017 ↗
• InjuryMar 20, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 AND THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24655024 ↗
• InjuryMar 12, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24583373 ↗
• InjuryMar 9, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. THE LEAD WAS CONFIRMED FRACTURED UPON EXPLANT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24551868 ↗
• InjuryMar 9, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THE LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. THE LEAD WAS CONFIRMED FRACTURED UPON EXPLANT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24550040 ↗
• InjuryFeb 26, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY FOLLOWING A FEW RECENT FALLS. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24464211 ↗
• InjuryFeb 24, 2026High impedance

  IT WAS REPORTED THAT DURING A ROUTINE IPG REPLACEMENT THE LEAD WAS DIAGNOSED WITH HIGH IMPEDANCES. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433406 ↗
• InjuryFeb 19, 2026Low impedance

  IT WAS REPORTED THE PATIENT COULD NOT ENTER INTO MRI MODE. DIAGNOSTICS SHOWED LOW IMPEDANCES. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393913 ↗
• InjuryFeb 17, 2026High impedance

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 24365159 ↗
• InjuryDec 15, 2025High impedance; High impedance

  IT WAS REPORTED THE PATIENT WAS UNABLE TO ENTER INTO MRI MODE DUE TO HIGH IMPEDANCES. AS SUCH, SURGICAL INTERVENTION WAS UNDERTAKEN AND THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803588 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT THE IPG AND LEAD SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23727918 ↗
• InjuryNov 26, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEAD EXHIBITED HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658831 ↗
• InjuryNov 25, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THEIR LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23650518 ↗
• InjuryNov 20, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AT THE IPG SITE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED, AND THE LEAD REMAINED IMPLANTED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23610131 ↗
• InjurySep 12, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED RECHARGE BURDEN, AND INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23044099 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEAD ERODED THROUGH THE SKIN. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD OR EXTENSION IS AT FAULT.

  Patient problems: Erosion

  MAUDE report 23043581 ↗
• InjurySep 9, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ENTER THEIR DEVICE INTO MRI MODE DUE TO LOW IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23011941 ↗

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-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-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-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-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-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-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-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-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-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