SJM™ 3383Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05415067017918), received between Mar 26, 2019 and Aug 8, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “High impedance” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE LEAD EXTENSIONS ON (B)(6) 2025. THE IMPEDANCES RESOLVED. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22756939 ↗
• InjuryAug 8, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE LEAD EXTENSIONS ON (B)(6) 2025. THE IMPEDANCES RESOLVED. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22756936 ↗
• InjuryOct 24, 2024High impedance; High impedance

  IT WAS REPORTED, DURING THE 07 OCT 2024 IPG REPLACEMENT (RELATED MANUFACTURER REFERENCE NUMBER: (B)(4), THE LEAD WAS FOUND TO HAVE ALL HIGH IMPEDANCES. AS SUCH, THE EXTENSION WAS REMOVED AND IT WAS REVEALED THE IMPEDANCES WOULD CLEAR AFTER THE REMOVAL OF THE EXTENSION. AS A RESULT, THE EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant

  MAUDE report 20527722 ↗
• InjuryAug 14, 2024High impedance; High impedance

  ADDITIONAL INFORMATION WAS OBTAINED, REVEALING THAT THE PATIENT HAD EXPERIENCED INEFFECTIVE THERAPY, PRIOR TO SURGERY.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19980650 ↗
• InjuryAug 14, 2024High impedance; High impedance

  ADDITIONAL INFORMATION WAS OBTAINED, REVEALING THAT THE PATIENT HAD EXPERIENCED INEFFECTIVE THERAPY, PRIOR TO SURGERY.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19980646 ↗
• InjuryJun 1, 2024High impedance; High impedance

  IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON 3 CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD EXTENSION WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED. NOTE : IT IS UNKNOWN WHICH EXTENSION IS RELATED TO THIS ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 19444259 ↗
• InjuryDec 7, 2023High impedance; High impedance

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-05831, 1627487-2023-05489. IT WAS REPORTED THAT, DURING A LEAD REVISION PROCEDURE ON (B)(6) 2023, BOTH LEAD EXTENSIONS WERE FOUND TO HAVE HIGH IMPEDANCES. AS A RESULT, BOTH LEAD EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18288668 ↗
• InjuryDec 7, 2023High impedance; High impedance

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-05830, 1627487-2023-05489. IT WAS REPORTED THAT, DURING A LEAD REVISION PROCEDURE ON (B)(6) 2023, BOTH LEAD EXTENSIONS WERE FOUND TO HAVE HIGH IMPEDANCES. AS A RESULT, BOTH LEAD EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18288666 ↗
• InjuryOct 3, 2023Impedance Problem; Impedance Problem

  RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-04692, 3006705815-2023-06302. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AND INEFFECTIVE THERAPY DUE TO IMPEDANCES ON THE EXTENSIONS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE IPG WAS REPLACED, THE IPG POCKET WAS REVISED, AND THE EXTENSIONS WERE REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17858480 ↗
• InjuryFeb 14, 2023High impedance; High impedance

  IT WAS REPORTED DURING AN IPG REPLACEMENT THE ONE OF PATIENT'S EXTENSIONS HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH EXTENSIONS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376199 ↗
• InjuryApr 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-01680. RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2022-13630. RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-01985. IT WAS REPORTED THAT PATIENT UNDERWENT SURGICAL INTERVENTION AT UNKNOWN DATE WHEREIN THE EXTENSIONS, IPG WERE EXPLANTED AND THE CERVICAL LEAD TAILS WERE CUT FOR UNKNOWN REASON. ADDITIONAL SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 14047924 ↗
• InjuryApr 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-01680. RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2022-13630. RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-01984. IT WAS REPORTED THAT PATIENT UNDERWENT SURGICAL INTERVENTION AT UNKNOWN DATE WHEREIN THE EXTENSIONS, IPG WERE EXPLANTED AND THE CERVICAL LEAD TAILS WERE CUT FOR UNKNOWN REASON. ADDITIONAL SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 14047921 ↗
• InjuryJun 3, 2021Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THE PATIENT LOST EFFECTIVE THERAPY. DIAGNOSTICS INDICATED HIGH IMPEDANCES. IN TURN, THE EXTENSION WAS EXPLANTED. THERAPY WAS RESTORED POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11931134 ↗
• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED IRRITATION/PAIN AT THE EXTENSION SITE DUE TO MECHANICAL FRICTION. AS SUCH, SURGICAL INTERVENTION TOOL PLACE ON (B)(6) 2020 WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED WITH A NEW EXTENSION ADDRESSING THE ISSUE.

  Patient problems: Irritation; Pain

  MAUDE report 9693838 ↗
• InjuryMar 26, 2019High impedance; High impedance

  DEVICE 1 OF 2: REFERENCE MFR REPORT # 1627487-2019-03864.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8454231 ↗

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-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-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-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-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-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-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-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