Senza NIPG3000Recalls & reported problems

Summary

The FDA's MAUDE database contains 722 adverse event reports that list this exact device (DI 00813426020718), received between Jan 30, 2023 and Sep 30, 2026 — classified as 35 deaths, 687 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (155 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 722 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. A medical assessment from the physician regarding the nature of the infection was not available. The patient was hospitalized, and there have been no reports of further complications regarding this event.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50946398 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced incontinence, increased back pain, generalized pain, numbness, weakness, and other neurological symptoms. A medical assessment from the physician regarding the cause of the reported symptoms was not available. The patient subsequently underwent device removal. No further complications related to this event have been reported.

  Patient problems: Back pain; Incontinence; Neuropathy; Pain

  MAUDE report 50903673 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a bacterial infection (Staphylococcal infection) around the battery. 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: Bacterial Infection

  MAUDE report 50886481 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient acquired an infection at the implant 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 50859205 ↗
• InjurySep 22, 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 50854742 ↗
• InjurySep 22, 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 oral antibiotics, there have been no reports of further complications regarding this event.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50853722 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed cellulitis at the implant site. A medical assessment from the physician regarding the nature of the infection was not available. The patient was treated with oral and topical medications, as well as intravenous antibiotics. No further complications related to this event have been reported.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50853307 ↗
• InjurySep 18, 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 50817750 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain at implant site. A medical assessment regarding the nature of the reported issue was not available. The patient was hospitalized, and no further complications have been reported related to this event.

  Patient problems: Implant Pain

  MAUDE report 50817720 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced heat sensations on battery side during an MRI scan. The scan was aborted. The HCP confirmed that they did follow our MRI guidelines for her scan and stim was turned off prior to the scan. There have been no reports of further complications regarding this event.

  Patient problems: Burning Sensation

  MAUDE report 50817593 ↗
• 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 had the device removed and there have been no reports of further complications regarding this event.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50804596 ↗
• InjuryAug 7, 2026Insufficient Device Problem Information

  It was reported that the patient experienced pocket pain and heat sensations. The device was replaced during a revision procedure. No further complications have been reported related to this event.

  Patient problems: Burning Sensation; Implant Pain

  MAUDE report 50177860 ↗
• InjuryAug 7, 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 hospitalized, and there have been no reports of further complications regarding this event.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50176602 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient alleged the implanted device was defective and stated that the implanting surgeon advised that the device was defective and subsequently explanted the system. The patient further reported experiencing significant damage and falls following the explant procedure. No additional clinical information or physician assessment was available at the time of the report.

  Patient problems: Fall

  MAUDE report 50176072 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced wound healing issues and developed an infection at both the implant and lead incision sites. A medical assessment from the physician regarding the cause of the reported symptoms was not available. The patient was hospitalized, and the device was removed. There have been no reports of further complications related to this event.

  Patient problems: Impaired Healing; Insufficient Information; Unspecified Infection

  MAUDE report 50132465 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection at the implant site. A physician's assessment regarding the nature of the infection was not available. The patient was treated with oral antibiotics, and the pocket site infection is improving. There have been no reports of further complications related to this event.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50129792 ↗
• InjuryJul 27, 2026Insufficient Device Problem Information

  It was reported that the patient experienced sensations of heat at the battery site. A medical assessment regarding the cause of these symptoms was not available. The device was replaced. No further complications have been reported related to this event.

  Patient problems: Burning Sensation

  MAUDE report 50024501 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION. THE PHYSICIAN DID NOT BELIEVE IT WAS DEVICE RELATED. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS, THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 25861171 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEALING ISSUES AT THE IMPLANT SITE. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE CAUSE OF THE REPORTED SYMPTOMS WAS NOT AVAILABLE. THE PATIENT UNDERWENT COMPLETE DEVICE REMOVAL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Impaired Healing

  MAUDE report 25858860 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED IRRITATION POTENTIALLY RELATED TO AN ALLERGIC REACTION, REJECTION OF THE IMPLANT, OR A POSSIBLE INFECTION AT THE IMPLANT SITE. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND UNDERWENT DEVICE REMOVAL. PER HCP, THE EVENT WAS NOT CONSIDERED DEVICE-RELATED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

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

  MAUDE report 25829945 ↗
• InjuryJul 15, 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 25829929 ↗
• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE HCP STATED THAT THE PATIENT'S BODY REJECTED THE STIMULATOR. AS A RESULT, THE DEVICE WAS EXPLANTED. NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 25796903 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION INVOLVING THE AREAS WHERE THE DEVICE WAS IMPLANTED. THE PATIENT WAS HOSPITALIZED AND HAD THE DEVICE EXPLANTED, UNDERWENT A SURGICAL WASHOUT PROCEDURE, AND RECEIVED INTRAVENOUS ANTIBIOTIC. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 25738855 ↗
• InjuryJul 7, 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 ORAL ANTIBIOTICS; THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 25737927 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET PAIN. 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: Implant Pain

  MAUDE report 25634389 ↗