NA 3341Recalls & reported problems

Summary

The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 05414734402279), received between Jun 15, 2018 and Jun 8, 2026 — classified as 165 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (52 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 165 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT FOLLOWING RECENT WEIGHT LOSS AND TAKING A FALL, THE PATIENT EXPERIENCED SHOCKING SENSATIONS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE EXTENSIONS AND IPG WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 25423146 ↗
• InjuryJun 8, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT FOLLOWING RECENT WEIGHT LOSS AND TAKING A FALL, THE PATIENT EXPERIENCED SHOCKING SENSATIONS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE EXTENSIONS AND IPG WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 25423144 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AT THE LEADS, IPG, AND EXTENSION SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 23712229 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AT THE LEADS, IPG, AND EXTENSION SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 23712227 ↗
• InjuryNov 26, 2025High impedance; Insufficient Device Problem Information; High impedance; Insufficient Device Problem Information

  ADDITIONAL INFORMATION INDICATES THE PATIENT EXPERIENCED INEFFECTIVE THERAPY AND ONE OF THE EXTENSIONS EXHIBITED HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025, WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE. IT IS UNKNOWN WHICH EXTENSION ATTRIBUTED TO THIS ISSUE.

  Patient problems: Inadequate Pain Relief; Insufficient Information

  MAUDE report 23660177 ↗
• InjuryAug 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEAD HAD HIGH IMPEDANCES AND THE PATIENT'S EXTENSIONS WERE CAUSING THE PATIENT'S LEADS TO HAVE HIGH IMPEDANCES. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD ATTRIBUTED TO THIS ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEAD AND EXTENSIONS WERE EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22923887 ↗
• InjuryAug 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEAD HAD HIGH IMPEDANCES AND THE PATIENT'S EXTENSIONS WERE CAUSING THE PATIENT'S LEADS TO HAVE HIGH IMPEDANCES. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD ATTRIBUTED TO THIS ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEAD AND EXTENSIONS WERE EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22923885 ↗
• InjuryMay 19, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEADS AND EXTENSION HAD HIGH IMPEDANCES. THE INVESTIGATION DID NOT DETERMINE WHICH LEADS AND EXTENSION ATTRIBUTED TO THIS ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEADS AND EXTENSION WERE EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22049397 ↗
• InjuryApr 30, 2025Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT HAS INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES ON THEIR LEADS. DURING THE LEAD REVISION ON (B)(6) 2025 THE EXTENSIONS WERE DISCOVERED TO BE CORRODED, DISCOLORED, AND THE MATERIAL APPEARED TO HAVE DETERIORATED. THE EXTENSIONS WERE THEN EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934715 ↗
• InjuryApr 27, 2025Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT HAS INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES ON THEIR LEADS. DURING THE LEAD REVISION ON (B)(6) 2025 THE EXTENSIONS WERE DISCOVERED TO BE CORRODED, DISCOLORED, AND THE MATERIAL APPEARED TO HAVE DETERIORATED. THE EXTENSIONS WERE THEN EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915980 ↗
• InjuryApr 27, 2025Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT HAS INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES ON THEIR LEADS. DURING THE LEAD REVISION ON (B)(6) 2025 THE EXTENSIONS WERE DISCOVERED TO BE CORRODED, DISCOLORED, AND THE MATERIAL APPEARED TO HAVE DETERIORATED. THE EXTENSIONS WERE THEN EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915979 ↗
• InjuryMay 17, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN AT THE IPG SITE. IT WAS ALSO REPORTED THE PATIENT HAD HIGH IMPEDANCES ON THE RIGHT OCCIPITAL LEAD AND RIGHT EXTENSION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE IPG, THE RIGHT OCCIPITAL LEAD AND RIGHT EXTENSION WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS RESTORED POST-OP. IT IS UNKNOWN WHICH OCCIPITAL LEAD AND WHICH EXTENSION WERE LIABLE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 19342309 ↗
• InjuryJan 24, 2024Disconnection; Disconnection

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00406, 1627487-2024-00407, 1627487-2024-00408. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. LEAD DIAGNOSTICS SHOWED THAT ALL THE LEADS HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN, AND DURING PROCEDURE, IT WAS NOTED ONE OF THE 3166 LEADS HAD PULLED OUT OF THE EXTENSION CAUSING CONCERN ABOUT THE INTEGRITY OF THE EXTENSION. IN TURN, THE SYSTEM THE LEADS AND EXTENSION WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18568155 ↗
• InjuryApr 11, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE EXTENSION WOULD NOT ADVANCE INTO THE IPG. THE EXTENSION WAS LEFT IMPLANTED AND THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718337 ↗
• InjuryJan 16, 2023No Apparent Adverse Event; No Apparent Adverse Event

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-00169, 1627487-2023-00136. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE IPG SITE. ADDITIONALLY, THEY WERE EXPERIENCING INEFFECTIVE THERAPY DUE TO AUTOREDUCING ON ONE LEAD DUE TO HIGH IMPEDANCES. DURING THE PROCEDURE ON (B)(6) 2023, THE IPG POCKET WAS MOVED TO A LOWER POSITION AND THE EXTENSIONS WERE REPLACED DUE TO PHYSICIAN NOT BEING COMFORTABLE REPLACING THE LEAD. THE REPLACEMENT OF EXTENSIONS DID NOT RESOLVE THE IMPEDANCE ISSUE, THEREFORE FURTHER INTERVENTION MAY TAKE PLACE TO RESOLVE THE ISSUE. EFFECTIVE THERAPY WAS RESTORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16178743 ↗
• InjuryJan 16, 2023No Apparent Adverse Event; No Apparent Adverse Event

  RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-00169 AND 1627487-2023-00137. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE IPG SITE. ADDITIONALLY, THEY WERE EXPERIENCING INEFFECTIVE THERAPY DUE TO AUTOREDUCING ON ONE LEAD DUE TO HIGH IMPEDANCES. DURING THE PROCEDURE ON (B)(6) 2023, THE IPG POCKET WAS MOVED TO A LOWER POSITION AND THE EXTENSIONS WERE REPLACED DUE TO PHYSICIAN NOT BEING COMFORTABLE REPLACING THE LEAD. THE REPLACEMENT OF EXTENSIONS DID NOT RESOLVE THE IMPEDANCE ISSUE, THEREFORE FURTHER INTERVENTION MAY TAKE PLACE TO RESOLVE THE ISSUE. EFFECTIVE THERAPY WAS RESTORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16178711 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-07167, 1627487-2022-07168, 1627487-2022-07169, AND 1627487-2022-07170.. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BACTERIAL SKIN INFECTION NEAR THE INCISION SITE OF THE PATIENT'S LEADS AND LEAD EXTENSION. AS A PRECAUTION, AN EXPLORATORY SURGERY WAS UNDERTAKEN ON (B)(6) 2022 TO INSPECT THE INCISION, AFTER WHICH THE PHYSICIAN CONCLUDED THAT THE INCISION WAS NOT INFECTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16086119 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-06865, 3006705815-2022-18711,1627487-2022-06866, 1627487-2022-06868, 1627487-2022-06869, AND 1627487-2022-06399. IT WAS REPORTED THAT THE INFECTION SPREAD TO THE FULL SYSTEM. AS SUCH, THE PATIENT'S SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15983517 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-06865, 3006705815-2022-18711, 1627487-2022-06867, 1627487-2022-06868, 1627487-2022-06869, AND 1627487-2022-06399. IT WAS REPORTED THAT THE INFECTION SPREAD TO THE FULL SYSTEM. AS SUCH, THE PATIENT'S SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15983516 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-06726, 1627487-2022-06727, AND 3006705815-2022-18619. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNCOMFORTABLE STIMULATION, AND FLUID ACCUMULATION WAS FOUND ON THE LEADS AND THE EXTENSION. THE PATIENT'S IPG HAD ALSO MIGRATED. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN IN WHICH THE LEADS AND EXTENSION WERE REPLACED WHILE THE IPG WAS REPOSITIONED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE EXTENSIONS ATTRIBUTED TO THE EVENT.

  Patient problems: Fluid Discharge

  MAUDE report 15953556 ↗
• InjuryJun 3, 2022Fracture; Fracture

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2022-03142. IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS AUTOREDUCING AND PATIENT WAS RECEIVING INADEQUATE THERAPY. LEAD DIAGNOSTICS INDICATED HIGH IMPEDANCES ON MULTIPLE CONTACTS IN THE CERVICAL AND LUMBAR LEADS (RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2022-02396; 1627487-2022-02397). AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN IT WAS DISCOVERED THERE WAS A FRACTURE OF THE LEAD EXTENSION (RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03142). BOTH THORACIC LEADS AND EXTENSIONS WERE EXPLANTED. A NEW OCTRODE WAS PLACED AT T8 TO ADDRESS THE ISSUE. DURING THE PROCEDURE, THE PHYSICIAN REPLACED THE IPG ELECTIVELY. THE SET SCREW ON PORT 1-8 OF THE NEW IPG SHIFTED AND WAS REPOSITIONED AND PHYSICIAN BEGAN CLOSING . AS THE PHYSICIAN WAS COMPLETING THE FINAL SUTURES, THE PATIENT WENT INTO CARDIAC ARREST AND WAS FLIPPED (RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-14759). ONCE THE PATIENT WAS STABLE, THE PHYSICIAN COMPLETED THE CASE WITH THE PATIENT LAYING ON THEIR SIDE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14598402 ↗
• InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03028. IT WAS REPORTED ONE OF THE LEADS HAD BEGUN TO PROTRUDE. THE LEAD WAS ALSO POTENTIALLY INFECTED. IN TURN, THE LEAD AND EXTENSIONS WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Erosion

  MAUDE report 14522284 ↗
• InjuryMay 15, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-02777, 1627487-2022-02778, AND 1627487-2022-02779. IT WAS REPORTED THAT THE PATIENT HAD A FALL IN (B)(6) 2022 AND LOST EFFECTIVE THERAPY. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE LEADS WERE EXPLANTED AND REPLACED, RESOLVING THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14404068 ↗
• InjuryMay 3, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-02171. IT WAS REPORTED THE PATIENT WAS EXPERIENCING UNCOMFORTABLE STIMULATION WHEN PRESSING ON THE IPG. DIAGNOSTIC TESTING SHOWED HIGH IMPEDANCE ON ONE CONTACT. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE PHYSICIAN REPLACED THE EXTENSIONS TO ADDRESS THE ISSUE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 14269348 ↗
• InjuryMay 3, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-02172. IT WAS REPORTED THE PATIENT WAS EXPERIENCING UNCOMFORTABLE STIMULATION WHEN PRESSING ON THE IPG. DIAGNOSTIC TESTING SHOWED HIGH IMPEDANCE ON ONE CONTACT. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE PHYSICIAN REPLACED THE EXTENSIONS TO ADDRESS THE ISSUE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 14269316 ↗

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-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-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-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-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-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