Exclaim™ 3224 (UDI 05414734406178)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734406178), received between Oct 23, 2018 and Jun 11, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “High impedance” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2023Impedance Problem; Impedance Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2023 WHEREIN THE PATIENT'S SCS SYSTEM WAS EXPLANTED, REPLACED, AND THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17102303 ↗
• InjuryDec 30, 2020High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH IMPEDANCE. THE PATIENT LOST THERAPY APPROXIMATELY ONE MONTH AGO. AS A RESULT, THE PATIENT MAY UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11096099 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED HEADACHES AND RINGING IN THE EAR DUE TO AN ALLEGED CSF LEAK. THE PHYSICIAN CHECKED THE AREA WHERE THE PADDLE LEAD WAS IMPLANTED, AND A CSF LEAK WAS NOT PRESENT. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. HEADACHES HAVE RESOLVED.

  Patient problems: Headache

  MAUDE report 10467474 ↗
• InjuryJul 17, 2020High impedance; High impedance

  DEVICE 1 OF 2 REFERENCE MFR. REPORT#: 1627487-2020-22955.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10292816 ↗
• InjuryDec 11, 2018Fracture; Fracture

  IT WAS REPORTED THE PATIENT EXPERIENCED LOSS OF STIMULATION. X-RAYS INDICATED THE LEAD WAS FRACTURED. AS A RESULT, THE PATIENT'S LEAD WAS EXPLANTED AND REPLACED. THERAPY HAS BEEN RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8150746 ↗
• InjuryOct 23, 2018Impedance Problem; Adverse Event Without Identified Device or Use Problem; Impedance Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 3. REFERENCE MFR. REPORT: 1627487-2018-10440. REFERENCE MFR. REPORT: 1627487-2018-10442. FOLLOW UP INFORMATION IDENTIFIED THE REASON FOR THE SYSTEM EXPLANT AND REPLACEMENT ON (B)(6) 2018. THE PATIENT¿S IPG WAS INOPERABLE, AND THE PATIENT¿S TWO LEADS SHOWED INVALID IMPEDANCES.

  Patient problems: Inadequate Pain Relief; No Consequences Or Impact To Patient

  MAUDE report 7996086 ↗

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-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-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-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-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-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