Quattrode® 3159Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05414734401630), received between Jan 21, 2020 and Nov 3, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED. IT IS UNKNOWN WHICH LEAD WAS AT FAULT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23455732 ↗
• InjuryJul 30, 2025High impedance; High impedance

  IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO A HIGH IMPEDANCE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD WAS IMPEDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22671749 ↗
• InjurySep 24, 2023Fracture; Fracture

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-04510. IT WAS REPORTED THAT DURING PATIENT'S IPG REPLACEMENT SURGERY (SEE RELATED MANUFACTURER REFERENCE NUMBER 1627487-2023-04510), THE PHYSICIAN OBSERVED THAT THE LEAD APPEARED TO BE FRACTURED OR KINKED. INTRA-OP LEAD DIAGNOSTICS SHOWED THAT THE LEAD HAD HIGH IMPEDANCES ON ALL CONTACTS. THE PROCEDURE WAS COMPLETED, AND THERAPY WAS RESTORED USING THE OTHER LEAD. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THIS ISSUE AT A LATER DATE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 17805239 ↗
• InjuryAug 26, 2021High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES THE LEAD WAS REPLACED TO ADDRESS THE ISSUE. PATIENT HAD EFFECTIVE THERAPY POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12374921 ↗
• InjuryAug 26, 2021High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATES THE LEAD WAS REPLACED TO ADDRESS THE ISSUE. PATIENT HAD EFFECTIVE THERAPY POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12374912 ↗
• InjuryAug 17, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY ON (B)(6) 2020, WHEREIN THEIR IMPLANTABLE PULSE GENERATOR WAS REPLACED. LEADS WERE PREVIOUSLY REPORTED ON BUT ARE NO LONGER REPORTABLE AS IPG WAS RESPONSIBLE FOR INEFFECTIVE STIMULATION. PATIENT IS STABLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10417396 ↗
• InjuryAug 17, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY ON (B)(6) 2020, WHEREIN THEIR IMPLANTABLE PULSE GENERATOR WAS REPLACED. LEADS WERE PREVIOUSLY REPORTED ON BUT ARE NO LONGER REPORTABLE AS IPG WAS RESPONSIBLE FOR INEFFECTIVE STIMULATION. PATIENT IS STABLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10417384 ↗
• InjuryMay 29, 2020High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-21178; RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-21179; RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-21180. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON MULTIPLE CONTACTS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2020 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED. ISSUE RESOLVED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10102923 ↗
• InjuryMay 29, 2020High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER:1627487-2020-21178, RELATED MANUFACTURER REFERENCE NUMBER:1627487-2020-21179, RELATED MANUFACTURER REFERENCE NUMBER:1627487-2020-21181. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON MULTIPLE CONTACTS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2020 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED. ISSUE RESOLVED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10102915 ↗
• InjuryMar 20, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-02931, 1627487-2020-02933, 1627487-2020-02934. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9858276 ↗
• InjuryMar 19, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-02932, 1627487-2020-02933, 1627487-2020-02934. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9858274 ↗
• InjuryJan 21, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBERS: 1627487-2020-00584, 1627487-2020-00585, 1627487-2020-00586, 1627487-2020-00587, 1627487-2020-00590, 1627487-2020-00591. . IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY FROM THEIR SYSTEM. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9610866 ↗
• InjuryJan 21, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT NUMBERS: 1627487-2020-00584, 1627487-2020-00585, 1627487-2020-00586, 1627487-2020-00589, 1627487-2020-00590, 1627487-2020-00591. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY FROM THEIR SYSTEM. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9610865 ↗

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-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-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-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