Quattrode™ 3149 (UDI 05414734406055)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734406055), received between Feb 22, 2019 and Oct 2, 2024 — classified as 8 injuries.

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

• InjuryOct 2, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S OCCIPITAL LEADS MIGRATED. AS A RESULT, THE LEADS WERE EXPLANTED AND LATER REPLACED VIA SURGICAL INTERVENTION ON (B)(6) 2024.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20352164 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEAD ERODED THROUGH THE SKIN. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH LEAD ATTRIBUTED TO THIS ISSUE. BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 4918711.

  Patient problems: Erosion

  MAUDE report 18743575 ↗
• InjuryOct 2, 2022Migration; Migration

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-05387. IT WAS REPORTED THE PATIENT¿S LEAD MIGRATED. AS A RESULT, IT WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15526181 ↗
• InjuryOct 2, 2022Migration; Migration

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-05386. IT WAS REPORTED THE PATIENT¿S LEAD MIGRATED. AS A RESULT, IT WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15526180 ↗
• InjuryMay 1, 2019High impedance; High impedance

  DEVICE 1 OF 4. REFERENCE MFR. REPORT#: 1627487-2019-05208. 1627487-2019-05209. 1627487-2019-05210.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8571546 ↗
• InjuryMay 1, 2019High impedance; High impedance

  DEVICE 2 OF 4 . REFERENCE MFR. REPORT#: 1627487-2019-05207, 1627487-2019-05209, 1627487-2019-05210. IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE. IN TURN, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2019 WHEREIN THE PATIENT¿S CERVICAL SYSTEM WAS EXPLANTED AND REPLACED. THERAPY HAS BEEN RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8571545 ↗
• InjuryFeb 22, 2019Impedance Problem; Impedance Problem

  DEVICE 2 OF 2; REFERENCE MFR. REPORT # 1627487-2019-02613.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8361531 ↗
• InjuryFeb 22, 2019Impedance Problem; Impedance Problem

  DEVICE 1 OF 2; REFERENCE MFR. REPORT # 1627487-2019-02614.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8361528 ↗

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-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-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-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-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-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