Omnia NIPG2500 (UDI 00813426020602)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,532 adverse event reports that list this exact device (DI 00813426020602), received between Dec 19, 2019 and Sep 30, 2026 — classified as 318 deaths, 1,212 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (108 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 1,532 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient acquired an infection. Per the HCP, the infection was not related to the device but was attributed to wound healing issues. The patient was hospitalized, treated with oral and IV antibiotics, and subsequently underwent device removal. There have been no reports of further complications related to this event.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50946836 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection accompanied by an allergic reaction. According to the medical assessment, the infection was not believed to be device-related. The patient was hospitalized and treated with medication. No further complications related to this event have been reported.

  Patient problems: Hypersensitivity/Allergic reaction; Insufficient Information; Unspecified Infection

  MAUDE report 50927287 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient acquired an infection. A medical assessment from the physician regarding the nature of the infection was not available. The patient had the device removed and there have been no reports of further complications regarding this event.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50897618 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50860226 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50860077 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection that resulted in a wound issue, which is still healing. A medical assessment from the physician regarding the nature of the infection was not available. The patient underwent device removal, and no further complications related to this event have been reported.

  Patient problems: Impaired Healing; Insufficient Information; Unspecified Infection

  MAUDE report 50858484 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced worsening pain due to the implant. The patient had the device removed. There have been no reports of further complications regarding this event.

  Patient problems: Pain

  MAUDE report 50858471 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced numbness, shocking and heat sensations, and scar tissue buildup. The patient¿s right upper buttock, where the device was implanted, became hardened and developed a significant infection with tissue necrosis. The patient underwent surgical removal of the infected and damaged tissue and was left with permanent scarring as a result. A medical assessment from the physician regarding the nature of the infection and the other reported medical issues was not available. The patient subsequently had the device removed, and there have been no further reports of complications related to this event.

  Patient problems: Burning Sensation; Insufficient Information; Necrosis; Numbness; Pain; Unspecified Infection

  MAUDE report 50817651 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced dizziness and lower leg pain, resulting in a loss of balance and a fall down a flight of stairs at home. The patient also experienced pain that began at the base of the skull and radiated to the lower neck and shoulders. Subsequently, the patient was diagnosed with gastroparesis and continues to seek treatment for this condition to date. The patient also reported a permanent injury that required hospitalization. A medical assessment from the physician regarding the cause of the reported events was not available. The patient had the device removed.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Dizziness; Pain

  MAUDE report 50817609 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient acquired an infection. A medical assessment from the physician regarding the nature of the infection was not available. The patient was treated with antibiotics; there have been no reports of further complications regarding this event.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50805869 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced wound dehiscence following a fall. A medical assessment from the physician regarding the cause of the reported event was not available. The patient was treated with antibiotics, and there have been no reports of further complications regarding this event.

  Patient problems: Wound Dehiscence

  MAUDE report 50174298 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain, as well as irritation at her kidneys. 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: Pain; Unspecified Kidney or Urinary Problem

  MAUDE report 50173978 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced shocking sensations. The patient underwent a revision procedure during which the device was replaced. No further complications have been reported regarding this event.

  Patient problems: Pain

  MAUDE report 50098690 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain. 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: Pain

  MAUDE report 50060709 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a staph infection behind the spinal cord stimulator. A medical assessment from the physician regarding the nature or cause of the reported infection was not available. The patient was hospitalized. There have been no reports of further complications related to this event.

  Patient problems: Bacterial Infection

  MAUDE report 50039446 ↗
• InjuryJul 27, 2026Insufficient Device Problem Information

  It was reported that the patient acquired an infection. A medical assessment from the physician regarding the nature of the infection was not available. The patient had the device removed and there have been no reports of further complications regarding this event.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50024335 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET PAIN AND COGNITIVE DECLINE. A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE REMOVED, AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED RELATED TO THIS EVENT.

  Patient problems: Cognitive Changes; Implant Pain

  MAUDE report 25858188 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED A BACTERIAL INFECTION INVOLVING THE SPINAL CORD. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT UNDERWENT A SURGICAL INTERVENTION, WAS HOSPITALIZED, AND RECEIVED IV ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 25829904 ↗
• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND HEALING ISSUES. THE HCP STATED THAT, FOLLOWING MEDICAL ASSESSMENT, THE HEALING ISSUES WERE RELATED TO AN INFECTION. A PHYSICIAN ASSESSMENT REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE DEVICE WAS EXPLANTED. NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: Impaired Healing; Insufficient Information; Unspecified Infection

  MAUDE report 25796955 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT SURGICAL SITE. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 25738899 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT IMPLANT AND LEAD SITE. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS, THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 25696103 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEALING ISSUES AND DEVELOPED AN INFECTION. A PHYSICIAN'S ASSESSMENT REGARDING THE NATURE OF THE REPORTED INFECTION WAS NOT AVAILABLE. THE PATIENT WAS HOSPITALIZE AND THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: Impaired Healing; Insufficient Information; Unspecified Infection

  MAUDE report 25664325 ↗
• InjuryJun 26, 2026Adverse 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 25634360 ↗
• InjuryJun 16, 2026Insufficient Device Problem Information

  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 25523044 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE POCKET SITE, WHICH RESULTED IN SCIATIC PAIN. PER THE PHYSICIAN, THE PATIENT EXPERIENCED OVERSTIMULATION, AND THE DEVICE WAS SUBSEQUENTLY EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Implant Pain; Neuralgia

  MAUDE report 25522996 ↗