Senza® NIPG1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00813426020008), received between Nov 15, 2015 and May 30, 2025 — classified as 5 deaths, 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• DeathMay 30, 2025Adverse 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 PASSED AWAY DUE TO SEPSIS. 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; Sepsis

  MAUDE report 22117799 ↗
• InjuryMar 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING SENSATION FOLLOWED BY A TINGLING SENSATION WHEN CHARGING THE DEVICE. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE DEVICE WAS REPLACED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 21716181 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET PAIN SEVERAL YEARS AGO. AN ASSESSMENT BY A HEALTHCARE PROFESSIONAL REGARDING THE CAUSE OF THIS REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT UNDERWENT EXPLANTATION AT THE TIME, YET STILL REPORTS POCKET PAIN.

  Patient problems: Implant Pain

  MAUDE report 19779696 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE DEVICE REMOVED FOR UNKNOWN REASON. 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 19468902 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TINGLING AND SHOCKING SENSATIONS, DESCRIBED AS VIBRATIONS, IN THEIR CHEST AND ABDOMEN. SYMPTOMS PERSISTED REGARDLESS OF WHETHER THERAPY WAS ON OR OFF. NO MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE REPORTED SYMPTOMS WAS AVAILABLE. THE DEVICE WAS REPLACED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 18725497 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A PRESSURE ULCER AT THE IPG SITE. THE PHYSICIAN BELIEVES THAT THE PRIMARY CAUSE OF THE PRESSURE ULCER WAS THE PATIENT'S WEIGHT LOSS AND REDUCED MOBILITY, WHICH INCREASED PRESSURE AT THE IPG AREA AND CREATED THE ULCER. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 17436589 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL, BUT NONE WAS AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 14682742 ↗
• InjuryMar 22, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED. NO FURTHER INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL WAS AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 13845533 ↗
• DeathFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN A MEDICAL ASSESSMENT FROM A PHYSICIAN REGARDING THE CAUSE OF DEATH, BUT NONE WAS AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THE PASSING.

  Patient problems: Insufficient Information

  MAUDE report 13561186 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE DEVICE WAS REMOVED. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THE INCIDENT. NEVRO ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL BUT WAS UNSUCCESSFUL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8493903 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT HAD THE DEVICE REMOVED IN 2014. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THE INCIDENT. NEVRO ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL BUT WAS UNSUCCESSFUL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8493862 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE DEVICE WAS REMOVED. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THE INCIDENT. NEVRO ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL BUT WAS UNSUCCESSFUL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8493859 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE DEVICE WAS REMOVED. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THE INCIDENT. NEVRO ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE DEVICE REMOVAL BUT WAS UNSUCCESSFUL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 8489638 ↗
• DeathApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT PASSED AWAY. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THE PASSING. NEVRO ATTEMPTED TO OBTAIN A MEDICAL ASSESSMENT FROM THE PHYSICIAN BUT NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Death

  MAUDE report 8489636 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT EXPERIENCED SHOCKING SENSATIONS. THE PATIENT HAD BEEN USING THE DEVICE FOR 6 YEARS WITH NO PREVIOUS REPORTS OF SHOCKING ISSUES. THE DEVICE WAS EXPLANTED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 8192825 ↗
• InjuryJul 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT DURING AN IPG REVISION PROCEDURE, DARK GREY SOFT TISSUE WAS FOUND INSIDE THE POCKET SITE. THE PHYSICIAN REMOVED THE TISSUE AND PROCEEDED TO REPOSITION THE IPG AT THE NEW POCKET SITE. NO TESTS WERE PERFORMED ON THE TISSUE. THERE WERE NO PRIOR REPORTS BEFORE THE REVISION. NEVRO HAD ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE TISSUE BUT WAS UNSUCCESSFUL. THE PATIENT HAS RECOVERED WITHOUT SEQUELAE.

  Patient problems: Tissue Damage

  MAUDE report 7692698 ↗
• DeathJan 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT HAD PASSED AWAY ABOUT TWO YEARS AFTER IMPLANT. THE PATIENT'S CO-MORBIDITIES INCLUDED ISCHEMIC HEART DISEASE AND AN ABDOMINAL AORTIC ANEURYSM. PRIOR TO THE PATIENT'S PASSING, THE PATIENT HAD BEEN ADMITTED TO A HOSPITAL ON NUMEROUS OCCASIONS WITH FALLS, SHORTNESS OF BREATH AND ISSUES RELATED TO CONGESTIVE CARDIAC FAILURE. NEVRO HAD ATTEMPTED TO OBTAIN A MEDICAL ASSESSMENT FROM THE IMPLANTING PHYSICIAN BUT NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Death

  MAUDE report 7202670 ↗
• DeathJan 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO BY THE PATIENT'S FAMILY THAT THE PATIENT HAD PASSED AWAY DUE TO COMPLICATIONS FROM PROSTATE CANCER ROUGHLY A YEAR AFTER IMPLANT. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THE PASSING. NEVRO HAD ATTEMPTED TO OBTAIN A MEDICAL ASSESSMENT FROM THE IMPLANTING PHYSICIAN BUT NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Death

  MAUDE report 7202656 ↗
• InjuryJul 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A ROUTINE FOLLOW-UP, IT WAS REPORTED TO NEVRO THAT A PATIENT HAD ACQUIRED AN INFECTION. THE PATIENT WAS HOSPITALIZED AND TREATED WITH ANTIBIOTICS. THERE HAVE BEEN NO FURTHER REPORTS OF COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 6749354 ↗
• InjuryJul 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO IN (B)(6) 2016 THAT A PATIENT IN (B)(6) HAD DEVELOPED A HEMATOMA AT THE IMPLANT SITE SHORTLY AFTER THE IMPLANT PROCEDURE ((B)(6) 2014). THIS EVENT WAS REVEALED RECENTLY DURING A CONVERSATION WITH THE PATIENT. THE HEMATOMA WAS ASPIRATED AND THERE WAS NO OTHER REPORT OF SERIOUS INJURY RELATING TO THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 5811105 ↗
• InjuryDec 30, 2015Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED TO NEVRO THAT A PATIENT IN THE (B)(6) EXPERIENCED SHOCKING SENSATIONS WHEN THE IPG WAS TURNED ON. THE IPG WAS EXPLANTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 5337146 ↗
• MalfunctionNov 15, 2015Device Operates Differently Than Expected

  IT WAS REPORTED TO NEVRO THAT A PATIENT FROM (B)(6) EXPERIENCED "SHOCKS" AT HER IPG POCKET SITE AND THE SENSATION HAD CAUSED HER TO FEEL EXTREME PAIN. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO THE PAIN. IT WAS ALSO REPORTED THAT THE SHOCKS CAUSED CONSTANT PARESTHESIA DOWN BOTH LEGS. THE DEVICE WAS POWERED DOWN AND THE PATIENT IS WAITING FOLLOW UP FOR POSSIBLE REVISION. THE X-RAY SHOWED THAT THE LEADS HAD A SLIGHT MIGRATION. THE IMPEDANCES WERE CHECKED AND WERE NORMAL.

  Patient problems: Electric Shock; Pain

  MAUDE report 5223965 ↗