Omnia NIPG2500 (UDI 00813426020572)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00813426020572), received between Dec 2, 2019 and Apr 23, 2026 — classified as 14 deaths, 39 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 53 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24973047 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING SENSATIONS DURING AN MRI IN HER LEGS, AFTER BEEN THERE ON FOR ABOUT 6 MINUTES, THE MRI OF MID BACK WENT WELL. THE THERAPY WAS CONFIRMED BEING OFF PRIOR TO THE MRI. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE MRI SCAN WAS ABORTED. AS SOON AS THE MACHINE STOPPED, THE SYMPTOMS DISAPPEARED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 24345111 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET PAIN AND AN INCREASED SENSATION OF PAIN WHEN THE STIMULATOR WAS TURNED ON. A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE REMOVED, AND NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: Implant Pain; Pain

  MAUDE report 24189499 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 22566358 ↗
• InjuryJun 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE POCKET SITE. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT'S DEVICE WAS REPLACED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Implant Pain

  MAUDE report 22127012 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21998783 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 21756646 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE POCKET SITE. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 21731086 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET EROSION. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT UNDERWENT A REVISION AND A WOUND WASHOUT. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 21668865 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT THE POCKET SITE AND AN ADDITIONAL NON-LOCALIZED INFECTION. THE PATIENT WAS HOSPITALIZED AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20611869 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20205907 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE POCKET SITE. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT'S DEVICE WAS REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Implant Pain

  MAUDE report 20032432 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDESIRED STIMULATION, DISCOMFORT, AND HEART PALPITATIONS WHILE HAVING THE DEVICE OFF. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE DEVICE WAS EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Discomfort; Tachycardia; Undesired Nerve Stimulation

  MAUDE report 19812910 ↗
• DeathMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO AN UNKNOWN CANCER. AN HCP ASSESSMENT REGARDING THE CAUSE OF DEATH WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THE PASSING.

  Patient problems: Cancer

  MAUDE report 19260210 ↗
• DeathApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO UNKNOWN CAUSE OR COMORBIDITY. AN HCP ASSESSMENT REGARDING THE CAUSE OF DEATH WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THE PASSING.

  Patient problems: Insufficient Information

  MAUDE report 19093262 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO AN HEMORRHAGIC SHOCK AND A SEPSIS. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE CAUSE OF DEATH WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THE PASSING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock; Sepsis

  MAUDE report 18584987 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18493221 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD LEFT SHOULDER PAIN AND INADEQUATE PAIN RELIEF. THE PATIENT'S DEVICE WAS REMOVED. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 18378575 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POCKET PAIN WORSE THAN BASELINE PAIN, AND NEW FOOT DROP, CANNOT MOVE OR WALK DUE TO THE PAIN. THE PATIENT'S DEVICE WAS REMOVED. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Implant Pain; Inadequate Pain Relief; Paraplegia

  MAUDE report 18369802 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION AT THE POCKET SITE THAT LASTED ABOUT AN HOUR WHEN FINISHING CHARGING THE IPG. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT GOT A REVISION SURGERY TO ADDRESS THE ISSUE. THE PATIENT IS HEALING AND RECOVERING FROM SURGERY AND WILL CONTINUE TO PAY ATTENTION IF THE BURNING SENSATION PERSISTS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Burning Sensation

  MAUDE report 18358495 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION AT THE POCKET SITE THAT LASTED ABOUT AN HOUR WHEN FINISHING CHARGING THE IPG. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT GOT A REVISION SURGERY TO ADDRESS THE ISSUE. THE PATIENT IS HEALING AND RECOVERING FROM SURGERY AND WILL CONTINUE TO PAY ATTENTION IF THE BURNING SENSATION PERSISTS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Burning Sensation

  MAUDE report 18358442 ↗
• DeathDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO HEART AND LUNG ISSUES. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE CAUSE OF DEATH WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THE PASSING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Heart Problem

  MAUDE report 18297405 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENOSIS AT THE LEAD SITE. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Stenosis

  MAUDE report 17741748 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 17283286 ↗
• DeathJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO ASPIRATION PNEUMONIA. AN HCP ASSESSMENT REGARDING THE CAUSE OF DEATH WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THE PASSING.

  Patient problems: Aspiration Pneumonitis

  MAUDE report 17243659 ↗