Swift-Lock™ 1192 (UDI 05415067024084)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,400 adverse event reports that list this exact device (DI 05415067024084), received between Jun 12, 2018 and Sep 30, 2026 — classified as 1,395 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (86 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,400 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953872 ↗
• InjurySep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953855 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50904088 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50904086 ↗
• InjurySep 22, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861082 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50859430 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced an infection at an unknown site. As a result, surgical intervention was undertaken in (b)(6) 2023 wherein the leads and anchors were explanted to address the issue. Additionally, the IPG was explanted in (b)(6) 2024 for an unknown reason.

  Patient problems: Unspecified Infection

  MAUDE report 50859429 ↗
• OtherSep 17, 2026Fracture

  Patient problems: Inadequate Pain Relief

  MAUDE report 50811517 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following significant weight loss, the patient experienced pain at the Anchor site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the sutures on the anchors were revised, the site was irrigated and the patient was administered antibiotic to address the issue. It is unknown which Anchor the allegation is against.

  Patient problems: Implant Pain

  MAUDE report 50791389 ↗
• InjurySep 15, 2026Fracture

  It was reported patient lost effective therapy and was unable to enter MRI mode due to lead and anchor fractures. The issue was confirmed via X-Rays, though investigation was unable to identify which lead and anchor they were. Surgical intervention may be pending to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50777616 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Post Operative Wound Infection

  MAUDE report 50765969 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Post Operative Wound Infection

  MAUDE report 50765965 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced an infection at the lead site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the entire system was explanted to address the issue. Additionally, the patient was administered oral antibiotics to address the issue.

  Patient problems: Unspecified Infection

  MAUDE report 50763014 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced an infection at the lead site. As a result, surgical intervention was undertaken on (b)(6)2026 wherein the entire system was explanted to address the issue. Additionally, the patient was administered oral antibiotics to address the issue.

  Patient problems: Unspecified Infection

  MAUDE report 50763008 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced an infection at the IPG and lead site. As a result, surgical intervention was undertaken wherein the entire system was explanted on (b)(6)2026 to address the issue. The patient was also administered both oral and IV antibiotics to address the issue.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50123091 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced an infection at the IPG and lead site. As a result, surgical intervention was undertaken wherein the entire system was explanted on (b)(6)2026 to address the issue. The patient was also administered both oral and IV antibiotics to address the issue.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50123088 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS OCCIPITAL LEAD INCISION SITE WAS NOT HEALING PROPERLY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE OCCIPITAL LEADS AND ANCHORS WERE EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 25588195 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL ON THE IPG SITE. THE IPG SITE BEGAN ERODING, RESULTING IN INFECTION AT THE IPG AND LEAD INCISION SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED. THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25461845 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL ON THE IPG SITE. THE IPG SITE BEGAN ERODING, RESULTING IN INFECTION AT THE IPG AND LEAD INCISION SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED. THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25461838 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE IPG AND LEAD SITE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SCS SYSTEM WAS EXPLANTED. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS TO ADDRESS THE ISSUE. INFECTION WAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 25390320 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE IPG AND LEAD SITE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SCS SYSTEM WAS EXPLANTED. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS TO ADDRESS THE ISSUE. INFECTION WAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 25390314 ↗
• InjuryMay 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED TRAUMA AT THE LEAD SITES LEADING TO INFECTION, MRSA, AND BECOMING SEPTIC. PATIENT WAS HOSPITALIZED, SYSTEM WAS EXPLANTED, AND THE INFECTION HAS SINCE CLEARED. DATE OF EXPLANT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25344999 ↗
• InjuryMay 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED TRAUMA AT THE LEAD SITES LEADING TO INFECTION, MRSA, AND BECOMING SEPTIC. PATIENT WAS HOSPITALIZED, SYSTEM WAS EXPLANTED, AND THE INFECTION HAS SINCE CLEARED. DATE OF EXPLANT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25344997 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION INDICATES THAT THE INFECTION WAS TREATED WITH ORAL ANTIBIOTICS. THE INFECTION HAS RESOLVED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25337198 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE LEAD SITE. THE PATIENT EXPERIENCED FEVER, SWEATING, AND SWELLING AT THE LEAD SITE. THE PATIENT WAS SENT TO THE HOSPITAL FOR IV ANTIBIOTICS AND WAS SENT HOME WITH A PICC LINE TO ADDRESS THE ISSUE.

  Patient problems: Fever; Post Operative Wound Infection

  MAUDE report 25315813 ↗

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-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-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-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-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-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