Quattrode™ 3153Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734406062), received between Jun 15, 2018 and Jun 7, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “High impedance” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2023High impedance; High impedance

  MANUFACTURING REFERENCE NUMBER 1627487-2023-02714. IT WAS REPORTED THAT PATIENT'S LEADS HAD HIGH IMPEDANCES DURING IPG REPLACEMENT PROCEDURE. THE LEADS WERE EXPLANTED AND REPLACED. THERAPY RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17084137 ↗
• InjuryAug 7, 2020Disconnection; High impedance; Disconnection; High impedance

  DEVICE 3 OF 3; RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-23246, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-23247. IT WAS REPORTED THE PATIENT SHOWED HIGH IMPEDANCES ON TWO CONTACTS, ALTHOUGH STIMULATION WAS EFFECTIVE. X-RAYS REVEALED THE PATIENT¿S LEFT QUATTRODE WAS NOT FULLY INSERTED INTO THE EXTENSION. TO ADDRESS THE ISSUE, THE PHYSICIAN EXPLANTED AND REPLACED THE PATIENT¿S EXTENSION ON (B)(6) 2020. AFTER CHANGING THE EXTENSION, ONE IMPEDANCE ON THE RIGHT LEAD REMAINED HIGH, AND THE LEFT SIDE SHOWED NORMAL IMPEDANCES. POSTOPERATIVELY, EFFECTIVE STIMULATION WAS ACHIEVED. NOTE: IT IS UNKNOWN WHICH QUATTRODE SERIAL NUMBER WAS AFFECTED, THEREFORE BOTH ARE BEING REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382745 ↗
• InjuryAug 7, 2020Disconnection; High impedance; Disconnection; High impedance

  DEVICE 1 OF 3; RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-23247, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-23248. IT WAS REPORTED THE PATIENT SHOWED HIGH IMPEDANCES ON TWO CONTACTS, ALTHOUGH STIMULATION WAS EFFECTIVE. X-RAYS REVEALED THE PATIENT¿S LEFT QUATTRODE WAS NOT FULLY INSERTED INTO THE EXTENSION. TO ADDRESS THE ISSUE, THE PHYSICIAN EXPLANTED AND REPLACED THE PATIENT¿S EXTENSION ON (B)(6) 2020. AFTER CHANGING THE EXTENSION, ONE IMPEDANCE ON THE RIGHT LEAD REMAINED HIGH, AND THE LEFT SIDE SHOWED NORMAL IMPEDANCES. POSTOPERATIVELY, EFFECTIVE STIMULATION WAS ACHIEVED. NOTE: IT IS UNKNOWN WHICH QUATTRODE SERIAL NUMBER WAS AFFECTED, THEREFORE BOTH ARE BEING REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382736 ↗
• InjuryJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2018-05815. IT WAS REPORTED THE PATIENT COMPLAINED OF INEFFECTIVE STIMULATION THERAPY FROM HIS SCS SYSTEM. IMAGING TAKEN REVEALED ONE OF THE PATIENT'S LEADS PULLED OUT OF THE EPIDURAL SPACE. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7606295 ↗
• InjuryJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 1 OF 2, REFERENCE MFR REPORT: 1627487-2018-05816. IT WAS REPORTED THE PATIENT COMPLAINED OF INEFFECTIVE STIMULATION THERAPY FROM HIS SCS SYSTEM. IMAGING TAKEN REVEALED ONE OF THE PATIENT'S LEADS PULLED OUT OF THE EPIDURAL SPACE. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7606285 ↗

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-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-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-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-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-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-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