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Nevro NIPG2000Recalls & reported problems

Nevro Corp. · Senza II · Class 3 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Nevro Senza II spinal cord stimulator is implanted to relieve pain. Many of the 586 reports describe infections, pain and device removal, and some mention shock-like sensations and skin erosion. The reports include 134 deaths and 451 injuries, and reports fell from 47 in the previous 12 months to 27 in the latest 12 months. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
585
Deaths reported
134
Injuries reported
450
Recalls naming it
0

Summary

The FDA's MAUDE database contains 585 adverse event reports that list this exact device (DI 00813426020510), received between May 15, 2018 and Jul 10, 2026 — classified as 134 deaths, 450 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (33 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 9 reportsDec 2023: 6 reportsJan 2024: 5 reportsFeb 2024: 12 reportsMar 2024: 8 reportsApr 2024: 7 reportsMay 2024: 2 reportsJun 2024: 11 reportsJul 2024: 6 reportsAug 2024: 8 reportsSep 2024: 3 reportsOct 2024: 0 reportsNov 2024: 6 reportsDec 2024: 2 reportsJan 2025: 6 reportsFeb 2025: 8 reportsMar 2025: 2 reportsApr 2025: 4 reportsMay 2025: 7 reportsJun 2025: 7 reportsJul 2025: 0 reportsAug 2025: 2 reportsSep 2025: 2 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 3 reportsJan 2026: 2 reportsFeb 2026: 1 reportsMar 2026: 4 reportsApr 2026: 8 reportsMay 2026: 4 reportsJun 2026: 2 reportsJul 2026: 2 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202612
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem578
  • Insufficient Device Problem Information33
  • Appropriate Device Problem Term/Code Not Available2
  • Break1
  • Detachment of Device or Device Component1
  • Material Deformation1
  • Migration1
  • Migration or Expulsion of Device1

Patient problems

  • Insufficient Information150
  • Unspecified Infection129
  • Pain50
  • Death27
  • Implant Pain25
  • Impaired Healing19
  • Hematoma17
  • Wound Dehiscence17

Recent adverse event reports

The 25 most recent of 585 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING SENSATIONS DURING AN MRI EXAMINATION. THE DEVICE WAS TURNED OFF FOR THE SCAN, AND THE MRI EXAMINATION WAS ABORTED. THE PATIENT SUBSEQUENTLY TURNED THE DEVICE BACK ON AND EXPERIENCED STATIC SHOCK-LIKE SENSATIONS THROUGHOUT THE BODY. THE SYMPTOMS WORSENED, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT LATER TURNED THE DEVICE OFF AGAIN, AFTER WHICH THE SENSATIONS DECREASED. NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

    Patient problems: Pain

    MAUDE report 25787837 ↗
  • InjuryJul 1, 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 25677738 ↗
  • InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN EPIDURAL ABSCESS AND SUBSEQUENTLY EXPERIENCED A MRSA INFECTION. THE INFECTION WAS REPORTED TO HAVE ORIGINATED FROM A CAUSE UNRELATED TO THE STIMULATOR; HOWEVER, IT LATER SPREAD TO THE STIMULATOR BATTERY. THE PATIENT WAS HOSPITALIZED. NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

    Patient problems: Abscess; Bacterial Infection

    MAUDE report 25664456 ↗
  • InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AND EXPERIENCED SEVERE BACK PAIN. A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THE PATIENT WAS HOSPITALIZED, AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

    Patient problems: Back pain; Insufficient Information; Unspecified Infection

    MAUDE report 25429254 ↗
  • InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN EROSION AT THE IMPLANT SITE. A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

    Patient problems: Skin Erosion

    MAUDE report 25331190 ↗
  • InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING SENSATIONS AND INCREASED PAIN SYMPTOMS WHILE THE DEVICE WAS IMPLANTED. THE DEVICE WAS SUBSEQUENTLY EXPLANTED. FOLLOWING THE EXPLANT, THE PATIENT CONTINUES TO SUFFER FROM PAIN AND NERVE DAMAGE.

    Patient problems: Nerve Damage; Pain

    MAUDE report 25172175 ↗
  • InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN 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: Implant Pain

    MAUDE report 25083015 ↗
  • InjuryMay 4, 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 25075151 ↗
  • InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WORSENING PAIN, AS WELL AS WEAKNESS AND NUMBNESS IN THE LOWER EXTREMITIES REQUIRING PHYSICAL THERAPY. THE DEVICE WAS ULTIMATELY EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

    Patient problems: Muscle Weakness/Atrophy; Numbness; Pain

    MAUDE report 25034405 ↗
  • InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

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

    Patient problems: Pain

    MAUDE report 25023696 ↗
  • InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING SENSATIONS, URINARY INCONTINENCE AND INCREASED 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: Pain; Urinary Incontinence

    MAUDE report 25021460 ↗
  • InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem; Insufficient 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 24911894 ↗
  • InjuryApr 10, 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 24839649 ↗
  • InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT BRIEF SHOCKING SENSATIONS WHEN CHARGING AND POCKET PAIN. THE PHYSICIAN DOESN'T FEEL IT¿S A PATIENT ISSUE. THE PATIENT HAD THE DEVICE REPLACED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

    Patient problems: Implant Pain; Pain

    MAUDE report 24811337 ↗
  • InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEG PAIN AND ALLEGED THAT THE PHYSICIAN CAUSED SPINAL CORD DAMAGE, RESULTING IN PERMANENT IMPAIRMENT REQUIRING SUPPORT FOR WALKING. A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

    Patient problems: Limb Pain

    MAUDE report 24795178 ↗
  • InjuryApr 3, 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 24776122 ↗
  • InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem; Insufficient 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 24714629 ↗
  • InjuryMar 26, 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 24707149 ↗
  • InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AND WAS EXPERIENCING HEAT SENSATION. 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: Burning Sensation; Unspecified Infection

    MAUDE report 24682451 ↗
  • InjuryMar 12, 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 24583526 ↗
  • InjuryFeb 3, 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 24247469 ↗
  • InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A POST-SURGICAL INFECTION FOLLOWING A DECOMPRESSION AND DISCECTOMY UNRELATED TO NEVRO THERAPY OR THE DEVICE. THE INFECTION IS NOT BELIEVED TO BE DEVICE-RELATED. THE PATIENT WAS TREATED ANTIBIOTICS; THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

    Patient problems: Unspecified Infection

    MAUDE report 24132258 ↗
  • InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AND EXPERIENCED WOUND DEHISCENCE. ACCORDING TO THE MEDICAL ASSESSMENT, THE REPORTED ISSUE IS NOT BELIEVED TO BE DEVICE-RELATED. THE PATIENT HAD THE DEVICE REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

    Patient problems: Unspecified Infection

    MAUDE report 24100318 ↗
  • InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND SWELLING AT IPG SITE AND NOTED SHOCKING SENSATIONS WHILE CHARGING THE DEVICE. A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THE PATIENT UNDERWENT A REVISION WHERE THE DEVICE WAS REPOSITIONED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED RELATED TO THIS EVENT.

    Patient problems: Discomfort; Pain; Swelling/ Edema

    MAUDE report 23879132 ↗
  • InjuryDec 12, 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 23794408 ↗

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Sources and updates

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