NA 3383Recalls & reported problems

Summary

The FDA's MAUDE database contains 439 adverse event reports that list this exact device (DI 05414734402323), received between Jun 20, 2018 and Sep 21, 2026 — classified as 2 deaths, 437 injuries.

The most frequently reported specific device problem is “High impedance” (150 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 439 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Post Operative Wound Infection

  MAUDE report 50847787 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Post Operative Wound Infection

  MAUDE report 50847733 ↗
• InjuryAug 17, 2026High impedance

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 50287631 ↗
• InjuryAug 14, 2026High impedance

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 50263436 ↗
• InjuryMay 28, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO ALL HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD ADAPTER WAS REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25321743 ↗
• InjuryApr 21, 2026High impedance

  IT WAS REPORTED PATIENT HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND THE LEADS WERE TUNNELED DIRECTLY INTO THE IPG WHICH RESOLVED THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941757 ↗
• InjuryApr 21, 2026High impedance

  IT WAS REPORTED PATIENT HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND THE LEADS WERE TUNNELED DIRECTLY INTO THE IPG WHICH RESOLVED THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941753 ↗
• InjuryFeb 6, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCES ON THE CERVICAL LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE THE EXTENSION WAS IDENTIFIED TO BE AT FAULT. EXTENSION WAS REMOVED AND A NEW EXTENSION PLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24283047 ↗
• InjuryFeb 5, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON ALL CONTACTS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE EXTENSIONS WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24273264 ↗
• InjuryFeb 5, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON ALL CONTACTS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE EXTENSIONS WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24273260 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24039497 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24039027 ↗
• InjuryDec 22, 2025High impedance; High impedance

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 23870816 ↗
• InjuryNov 26, 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 BOTH THE IPG AND LEAD SITES. SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE SYSTEM WAS EXPLANTED. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS, AND THE INFECTION HAS SINCE RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 23660335 ↗
• InjuryNov 26, 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 BOTH THE IPG AND LEAD SITES. SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE SYSTEM WAS EXPLANTED. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS, AND THE INFECTION HAS SINCE RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 23660328 ↗
• InjuryNov 18, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED INDICATES THE EXTENSION WAS NOT EXPLANTED AND REPLACED.  THIS DEVICE IS NO LONGER CONSIDERED REPORTABLE ON THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583247 ↗
• InjuryNov 14, 2025Disconnection; Disconnection

  IT WAS REPORTED THE LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN A DISCONNECTION FROM THE HUB OF EXTENSION OBSERVED. AS A RESULT, THE EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23559666 ↗
• InjuryNov 14, 2025Disconnection; Disconnection

  IT WAS REPORTED THE LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN A DISCONNECTION FROM THE HUB OF EXTENSION OBSERVED. AS A RESULT, THE EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23559662 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS EXPERIENCING PAIN AT THE EXTENSION SITE. X-RAYS CONFIRMED THE EXTENSION IS TOO CLOSE TO THE SKIN. IN TURN, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE EXTENSIONS WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 23490765 ↗
• InjuryOct 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY AND PAIN AT THE EXTENSION SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG AND EXTENSIONS WERE EXPLANTED, AND THE LEAD WAS CUT AND LEFT IMPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 23388134 ↗
• InjuryOct 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY AND PAIN AT THE EXTENSION SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG AND EXTENSIONS WERE EXPLANTED, AND THE LEAD WAS CUT AND LEFT IMPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 23388133 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING BOTH EXTENSIONS WERE CAUSING PAIN. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE EXTENSIONS WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 23300310 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED, AND THE EXTENSIONS WERE EXPLANTED.

  Patient problems: Implant Pain

  MAUDE report 23067175 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AT THE IPG AND EXTENSION SITES. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG AND EXTENSIONS WERE EXPLANTED AND REPLACED.

  Patient problems: Implant Pain

  MAUDE report 23067168 ↗
• InjurySep 12, 2025High impedance; High impedance

  IT WAS REPORTED PATIENT LOST EFFECTIVE COVERAGE DUE TO HIGH IMPEDANCES ON THE CERVICAL LEAD. AS PATIENT UNDERWENT SURGICAL INTERVENTION TO ADDRESS THE ISSUE, THE LEFT EXTENSION AND THE LEAD WERE EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23043314 ↗

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-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-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-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-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-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