Penta™ 3228 (UDI 05414734406246)Recalls & reported problems

Summary

The FDA's MAUDE database contains 303 adverse event reports that list this exact device (DI 05414734406246), received between Jun 14, 2018 and Jun 18, 2026 — classified as 1 death, 302 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (87 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 303 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026High impedance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25555631 ↗
• InjuryJun 10, 2026High impedance

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 25462031 ↗
• InjuryMay 21, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A ROUTINE IPG REPLACEMENT, THE LEAD MAY HAVE BEEN DAMAGED AND EXHIBITS LOW IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247187 ↗
• InjuryMay 17, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ENTER MRI MODE DUE TO HIGH IMPEDANCES ON THEIR LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196491 ↗
• InjuryMay 13, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO MIGRATION OF THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS DONE ON (B)(6) 2026 TO REPLACE THE LEAD. THERAPY WAS RESTORED AND THERE WERE NO COMPLICATIONS DURING OR AFTER THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25164124 ↗
• InjuryApr 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 25037135 ↗
• InjuryMar 5, 2026Break

  IT WAS REPORTED THAT A PIECE OF THE LEAD WAS LEFT IMPLANTED DURING THE SYSTEM EXPLANT [RELATED MANUFACTURER NUMBER: 1627487-2018-01765, 1627487-2018-01766].

  Patient problems: Foreign Body In Patient

  MAUDE report 24524490 ↗
• InjuryFeb 20, 2026High impedance

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 24405166 ↗
• InjuryFeb 17, 2026High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2025-00551. IT WAS REPORTED PATIENT'S LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24370201 ↗
• InjuryFeb 6, 2026Temperature Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED HEATING SENSATION AT THE LEAD SITE DURING AN MRI. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Burning Sensation

  MAUDE report 24283466 ↗
• InjuryJan 23, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENTS LEAD WAS EXPLANTED AND REPLACED FOR AN UNKNOWN REASON ON (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 24168743 ↗
• InjuryJan 2, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED PATIENT'S SYSTEM WAS EXPLANTED AT AN UNKNOWN TIME DUE TO SYSTEM NOT PROVIDING SUFFICIENT PAIN RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23952726 ↗
• InjuryDec 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. ADDITIONALLY, THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG AND LEAD WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23926768 ↗
• InjuryDec 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION INDICATES THERE WERE NO ALLEGATIONS AGAINST THE LEAD.

  Patient problems: Insufficient Information

  MAUDE report 23926750 ↗
• InjuryDec 24, 2025High impedance; High impedance

  IT WAS REPORTED PATIENT'S LEAD HAD LOW IMPEDANCES PREVENTING PATIENT FROM HAVING MRI. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889324 ↗
• InjuryDec 22, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE THERAPY. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23871929 ↗
• InjuryDec 1, 2025High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES THE LEAD WAS REPLACED ON (B)(6) 2025 TO ADDRESS THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23688301 ↗
• InjuryOct 17, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ENTER THEIR DEVICE INTO MRI MODE DUE TO IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23329955 ↗
• InjurySep 5, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT IS UNABLE TO SET THE IPG INTO MRI MODE. IMPEDANCE CHECK REVEALED HIGH IMPEDANCE ON ONE OF THE CONTACTS. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY CONFIRMED POST OP. MRI MODE IS FUNCTIONAL POST OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974896 ↗
• InjurySep 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING IPG EXPLANT [RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2020-01471], THE PATIENT'S LEAD WAS CUT. THE PHYSICIAN ELECTED TO LEAVE IN IMPLANTED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965073 ↗
• InjuryAug 25, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED PATIENT'S LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22889144 ↗
• InjuryAug 18, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. IMAGING CONFIRMED LEAD MIGRATION. AS A RESULT, SURGICAL INTERVENTION MAY BY UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22829416 ↗
• InjuryAug 15, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO PLACE THEIR SYSTEM INTO MRI MODE. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819829 ↗
• InjuryAug 7, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 22745391 ↗
• InjuryJul 29, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIOR BACK SURGERY WHEREIN THE IPG WAS EXPLANTED (RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-03268). IT WAS FURTHER REVEALED THAT THE PENTA LEAD WAS CUT AND LEFT IMPLANTED DURING THE PREVIOUS PROCEDURE. TO ADDRESS THE ISSUE, THE LEAD WAS FULLY EXPLANTED AND REPLACED VIA SURGICAL INTERVENTION ON A (B)(6) 2025. A NEW IPG WAS ALSO IMPLANTED. THERAPY WAS RESTORED POST OP.

  Patient problems: Foreign Body In Patient

  MAUDE report 22642537 ↗

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-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-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-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-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-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-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-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