Quattrode® 3153Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734401616), received between Jul 11, 2018 and May 30, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT BOTH OF THE PATIENT'S LEADS WERE VISUALLY CONFIRMED TO BE FRACTURED DURING A PROCEDURE FOR NORMAL EOL IPG REPLACEMENT. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND 1 LEAD AND 1 IPG WERE REPLACED.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 22115032 ↗
• InjuryMay 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT BOTH OF THE PATIENT'S LEADS WERE VISUALLY CONFIRMED TO BE FRACTURED DURING A PROCEDURE FOR NORMAL EOL IPG REPLACEMENT. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND 1 LEAD AND 1 IPG WERE REPLACED.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 22115024 ↗
• InjuryOct 5, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-17499. IT WAS REPORTED THAT PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY IN THE RIGHT SIDE AS THE QUATTRODE LEADS WERE UNABLE TO PROVIDE ADEQUATE COVERAGE. TO ADDRESS THE ISSUE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE QUATTRODE LEADS WERE REPOSITIONED ON (B)(6) 2021. REPORTEDLY EFFECTIVE THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12579935 ↗
• InjuryApr 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 3 OF 6. REFERENCE MFR. REPORT#: 1627487-2020-03919. REFERENCE MFR. REPORT#: 1627487-2020-03920. REFERENCE MFR. REPORT#: 1627487-2020-03922. REFERENCE MFR. REPORT#: 1627487-2020-03923. REFERENCE MFR. REPORT#: 1627487-2020-03924. IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS EXPLANTED DUE TO INFECTION AT THE PATIENT'S IPG AND LEAD SITES. THE INFECTION RESOLVED OVER TIME VIA ANTIBIOTIC INTRAVENOUS THERAPY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 9959990 ↗
• InjuryApr 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 6. REFERENCE MFR. REPORT#: 1627487-2020-03919. REFERENCE MFR. REPORT#: 1627487-2020-03921. REFERENCE MFR. REPORT#: 1627487-2020-03922. REFERENCE MFR. REPORT#: 1627487-2020-03923. REFERENCE MFR. REPORT#: 1627487-2020-03924. IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS EXPLANTED DUE TO INFECTION AT THE PATIENT'S IPG AND LEAD SITES. THE INFECTION RESOLVED OVER TIME VIA ANTIBIOTIC INTRAVENOUS THERAPY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 9959988 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2019-06426. IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE COVERAGE OF THERAPY FOR MORE THAN A YEAR APPROXIMATELY (B)(6) 2018. MRI RESULTS SHOWED A PROGRESSION OF THE DISEASE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8660474 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2019-06429. IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE COVERAGE OF THERAPY FOR MORE THAN A YEAR APPROXIMATELY (B)(6) 2018. MRI RESULTS SHOWED A PROGRESSION OF THE DISEASE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8660467 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 3. REFERENCE MFR REPORT: 1627487-2018-06209, REFERENCE MFR REPORT: 1627487-2018-06211. IT WAS REPORTED THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION (REFERENCE MFR REPORTS: 1627487-2018-06255, 1627487-2018-06256). AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO HAVE THE DEVICE EXPLANTED; HOWEVER, THE PATIENT DESATURATED PRIOR TO INCISION AND THE PROCEDURE WAS ABORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 7679535 ↗

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-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-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-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-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-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