NA 3343Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 05414734402293), received between Jul 23, 2018 and Nov 18, 2025 — classified as 51 injuries.

The most frequently reported specific device problem is “High impedance” (13 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 51 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025High impedance; High impedance

  IT WAS REPORTED PATIENT'S SYSTEM WAS AUTORE-DUCING DUE TO HIGH IMPEDANCES ON THE LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED WHICH RESOLVED THE ISSUE AND THE LEAD REMAINS IMPLANTED. THERAPY WAS RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23583283 ↗
• InjuryDec 27, 2023Fracture; Fracture

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO ONE LEAD WITH HIGH IMPEDANCES AND A FRACTURED EXTENSION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD AND EXTENSION WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED. IT IS UNKNOWN WHICH LEAD OR EXTENSION IS LIABLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18406773 ↗
• InjuryAug 8, 2023High impedance; High impedance

  RELATED MANUFACTURER REPORT NUMBER: 3006705815-2023-02334, 1627487-2023-03752. ADDITIONAL INFORMATION WAS RECEIVED THAT BOTH OF THE PATIENT'S EXTENSIONS HAD HIGH IMPEDANCES AND THE PATIENT LOST EFFECTIVE THERAPY AS A RESULT. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG AND BOTH EXTENSIONS WERE REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17485289 ↗
• InjuryAug 8, 2023High impedance; High impedance

  RELATED MANUFACTURER REPORT NUMBER: 3006705815-2023-02334, 1627487-2023-03753. ADDITIONAL INFORMATION WAS RECEIVED THAT BOTH OF THE PATIENT'S EXTENSIONS HAD HIGH IMPEDANCES AND THE PATIENT LOST EFFECTIVE THERAPY AS A RESULT. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG AND BOTH EXTENSIONS WERE REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17485288 ↗
• InjuryJun 28, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-03045. DURING AN UNRELATED SURGICAL PROCEDURE ON (B)(6) 2023, ONE OF THE PATIENT'S FOUR CHANNEL EXTENSIONS WERE DAMAGED AND IT WAS DISCOVERED THAT ONE OF THE PATIENT'S LEADS WAS EXHIBITING HIGH IMPEDANCES. THE LEAD AND EXTENSION WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE EXTENSIONS ATTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17222183 ↗
• InjuryJun 22, 2023High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-02931. IT WAS REPORTED THAT THE PATIENT'S DUAL EXTENSION WAS EXHIBITING HIGH IMPEDANCES. DURING A SURGICAL PROCEDURE INTENDED TO EXPLANT THE DUAL EXTENSION ON (B)(6) 2023, ONE OF THE PATIENT'S LEADS WAS INADVERTENTLY EXPLANTED. THE PATIENT'S ENTIRE SYSTEM WAS THEN EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17187983 ↗
• InjuryJun 15, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT'S DUAL CHANNEL EXTENSION MIGRATED OUT OF THE IPG HEADER. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 IN WHICH THE EXTENSION WAS INSERTED INTO THE IPG HEADER TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17140372 ↗
• InjuryMay 26, 2023High impedance; High impedance

  PATIENT HAD HIGH IMPEDANCES ON LEADS. AS SUCH, SURGICAL INTERVENTION OCCURRED WHERE THE EXTENSION WAS REPLACED, HOWEVER, THE PHYSICIAN COULD NOT GET THE LEADS INTO THE ADAPTER. AS SUCH, THE EXTENSION WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17013670 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELT PAIN AT EXTENSION SITE. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2022 TO RESOLVE THE ISSUE. PATIENT IS RECEIVING EFFECTIVE THERAPY. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-06643.

  Patient problems: Implant Pain

  MAUDE report 15927992 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELT PAIN AT EXTENSION SITE. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2022 TO RESOLVE THE ISSUE. PATIENT IS RECEIVING EFFECTIVE THERAPY. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-06644.

  Patient problems: Implant Pain

  MAUDE report 15926594 ↗
• InjuryDec 5, 2022Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE THE DUAL PORT EXTENSION WAS CUT AND LEFT IMPLANTED BECAUSE IT WAS TOO INVASIVE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH EXTENSION WAS CUT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15916284 ↗
• InjuryMay 12, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  RELATED MANUFACTURER NUMBER: 1627487-2022-02645, 1627487-2022-02646,1627487-2022-02647, 1627487-2022-02649 IT WAS REPORTED THE PATIENT ENTIRE SYSTEM WAS EXPLANTED DUE TO INEFFECTIVE STIMULATION. DATE OF EXPLANT IS UNKNOWN.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14379621 ↗
• InjuryApr 1, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON ALL CONTACTS. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD EXTENSION WAS EXPLANTED AND REPLACED. POST-OPERATIVELY, STIMULATION THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13978846 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00472, 1627487-2022-00473, 1627487-2022-00474, 3006705815-2022-00419. IT WAS REPORTED THE PATIENT WAS DIAGNOSED WITH AN INFECTION AT THE CERVICAL INCISION SITES. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13386149 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-06155, 1627487-2021-18865, 1627487-2021-18866, 1627487-2021-18867, 1627487-2021-18868, 1627487-2021-18870. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION AND DISCOMFORT AT THE LEADS SITE. X-RAYS CONFIRMED LEAD MIGRATION. PATIENT ALSO EXPERIENCED DISCOMFORT AT THE IPG SITE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEADS WERE EXPLANTED AND REPLACED AND THE IPG WAS REPOSITIONED IN THE SAME POCKET SITE. PAIN AT THE POCKET SITE HAS RESOLVED. EFFECTIVE THERAPY WAS RESTORED.

  Patient problems: Discomfort

  MAUDE report 12960342 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-06155, 1627487-2021-18865, 1627487-2021-18866, 1627487-2021-18867, 1627487-2021-18868, 1627487-2021-18869. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION AND DISCOMFORT AT THE LEADS SITE. X-RAYS CONFIRMED LEAD MIGRATION. PATIENT ALSO EXPERIENCED DISCOMFORT AT THE IPG SITE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEADS WERE EXPLANTED AND REPLACED AND THE IPG WAS REPOSITIONED IN THE SAME POCKET SITE. PAIN AT THE POCKET SITE HAS RESOLVED. EFFECTIVE THERAPY WAS RESTORED.

  Patient problems: Discomfort

  MAUDE report 12960340 ↗
• InjuryNov 9, 2021High impedance; High impedance

  RELATED MANUFACTURER REPORT NUMBERS 1627487-2021-18229, 1627487-2021-18230. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY FROM THEIR SYSTEM. IT WAS FOUND THAT THE EXTENSIONS HAD HIGH IMPEDANCES. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE EXTENSIONS WERE EXPLANTED AND REPLACED. POSTOPERATIVELY, THE PATIENT HAS EFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12780423 ↗
• InjuryNov 9, 2021High impedance; High impedance

  RELATED MANUFACTURER REPORT NUMBERS 1627487-2021-18229, 1627487-2021-18231. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY FROM THEIR SYSTEM. IT WAS FOUND THAT THE EXTENSIONS HAD HIGH IMPEDANCES. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE EXTENSIONS WERE EXPLANTED AND REPLACED. POSTOPERATIVELY, THE PATIENT HAS EFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12780410 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-17409, 1627487-2021-17410. IT WAS REPORTED 2 OF THE PATIENTS EXTENSIONS ERODED THROUGH THE SKIN CAUSING HIGH IMPEDANCES. SURGICAL INTERVENTION TOOK PLACE IN WHICH THE 2 LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. ERODED AREA HAS HEALED AND THERAPY HAS BEEN RESTORED. NOTE: IT IS UNKNOWN WHICH 2 LEADS ERODED; THEREFORE ALL LEADS ARE BEING REPORTED.

  Patient problems: Erosion

  MAUDE report 12562299 ↗
• InjuryAug 31, 2021Fracture; Fracture

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-16694. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-16695. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-16698. IT WAS REPORTED PATIENT HAD LOSS OF THERAPY DUE TO THE INEFFECTIVE COVERAGE OF DUAL OCCIPITAL AND DUAL SUPRA ORBITAL SYSTEM. IMAGES INDICATED THAT THE DUAL EXTENSION WERE KINKED AND FRACTURED. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG AND ONE EXTENSION WAS EXPLANTED AND REPLACED WITH NEW ONES. POST OPERATIVELY EFFECTIVE STIMULATION WAS RESTORED. IT IS UNKNOWN WHICH EXTENSIONS ADDRESSED THE ISSUE AND THEREFORE ALL EXTENSIONS ARE BEING REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12393095 ↗
• InjuryAug 31, 2021Fracture; Fracture

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-16694. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-16696. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-16698. IT WAS REPORTED PATIENT HAD LOSS OF THERAPY DUE TO THE INEFFECTIVE COVERAGE OF DUAL OCCIPITAL AND DUAL SUPRA ORBITAL SYSTEM. IMAGES INDICATED THAT THE DUAL EXTENSION WERE KINKED AND FRACTURED. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG AND ONE EXTENSION WAS EXPLANTED AND REPLACED WITH NEW ONES. POST OPERATIVELY EFFECTIVE STIMULATION WAS RESTORED. IT IS UNKNOWN WHICH EXTENSIONS ADDRESSED THE ISSUE AND THEREFORE ALL EXTENSIONS ARE BEING

  Patient problems: Inadequate Pain Relief

  MAUDE report 12393093 ↗
• InjuryAug 18, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THE PATIENT'S SYSTEM WAS AUTOREDUCING. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE PATIENT'S LEAD EXTENSION WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12340454 ↗
• InjuryJun 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-03097. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15092. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15093. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15094. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-15095. IT WAS REPORTED THAT THE PATIENT WAS NO LONGER USING THEIR SYSTEM FOR AN UNKNOWN REASON. AS A RESULT, THE PHYSICIAN EXPLANTED THE SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 12055658 ↗
• InjuryApr 27, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-13495, 1627487-2021-13496, 1627487-2021-13497, 1627487-2021-13498, 1627487-2021-13500, 3006705815-2021-01987. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION WITH THE SCS SYSTEM. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE SYSTEM WAS EXPLANTED AN REPLACED. PATIENT NOW HAS EFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11731188 ↗
• InjuryApr 27, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-13495, 1627487-2021-13496, 1627487-2021-13497, 1627487-2021-13498, 1627487-2021-13499, 3006705815-2021-01987. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION WITH THE SCS SYSTEM. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE SYSTEM WAS EXPLANTED AN REPLACED. PATIENT NOW HAS EFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11731187 ↗

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-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-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-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-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-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-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-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