Nevro® LEAD1058-70BRecalls & reported problems

Summary

The FDA's MAUDE database contains 211 adverse event reports that list this exact device (DI 00813426020046), received between Dec 16, 2015 and Sep 30, 2026 — classified as 2 deaths, 169 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Fracture” (18 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 211 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 developed an infection at the lead incision site. A medical assessment from the physician regarding the nature of the infection was not available. The patient was treated with oral antibiotics. No further complications related to this event have been reported.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50946232 ↗
• InjurySep 22, 2026Insufficient Device Problem Information

  Patient problems: Pain

  MAUDE report 50857656 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERMANENT IMPLANT PROCEDURE FOLLOWING A SUCCESSFUL TRIAL, THE PHYSICIAN OBSERVED SIGNS OF INFECTION AT THE INCISION SITE. ACCORDING TO HIS ASSESSMENT, IT WAS A STANDARD/NORMAL (WOUND) INFECTION AT THE PUNCTURE/INCISION SITE, THE INFECTION WAS NOT CONSIDERED TO BE DEVICE-RELATED. THE PATIENT WAS ADMITTED TO THE HOSPITAL, UNDERWENT A SURGICAL WASHOUT PROCEDURE, AND SUBSEQUENTLY HAD THE LEADS REMOVED. THE PERMANENT DEVICE WAS NOT IMPLANTED. NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 25739251 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT THE EPIDURAL SPACE. 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 25430853 ↗
• InjuryMay 26, 2026Fracture

  FROM VOLUNTARY MEDWATCH MW5187100: PATIENT MENTIONED THEY WERE IN A CAR ACCIDENT AND HAD A NEVRO IMPLANT, AND THE NEVRO LEADS BROKE IN PROBABLY 2025, SO THEY REPLACED THE NEVRO IMPLANT WITH THEIR IMPLANT. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284278 ↗
• InjuryMar 20, 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 THE DEVICE WAS REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24651302 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION INDICATED THAT THE LEADS WERE NEVER EXPLANTED BUT THEY WERE MOVED OUT FROM THE EPIDURAL SPACE PER HCP DECISION. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414854 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND DEHISCENCE. A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THE PATIENT HAD THE LEADS EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 24222533 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacterial Infection

  MAUDE report 23779125 ↗
• InjurySep 16, 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 ACQUIRED AN INFECTION. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT WAS HOSPITALIZED AND TREATED WITH IV ANTIBIOTICS, AND THE DEVICE WAS REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 23062854 ↗
• MalfunctionJul 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FRACTURED LEAD. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT HAD THE WHOLE SYSTEM EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396498 ↗
• InjuryMar 24, 2025Adverse 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 LEAD AND ANCHOR SITE. AN HCP ASSESSMENT REGARDING THE CAUSE OF INFECTION WAS NOT AVAILABLE. THE PATIENT WAS HOSPITALIZED AND THE DEVICE WAS EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21684702 ↗
• InjuryMar 21, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE LEAD SITE BECAUSE THE LEADS CAME LOOSE. 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: Pain

  MAUDE report 21665708 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION IN THE BACK THAT REACHED THE SPINE. THE PATIENT UNDERWENT A WOUND WASHOUT, RECEIVED IV ANTIBIOTICS AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21554270 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN DOES NOT BELIEVE THE REPORTED INFECTION WAS DEVICE RELATED. HE BELIEVES THAT THERE WAS AN EXTERNAL INFECTION THROUGH THE SURGICAL WOUND.

  Patient problems: Unspecified Infection

  MAUDE report 20412877 ↗
• InjuryOct 9, 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 LEAD AND ANCHOR SITE, FROM THE BEGINNING OF THE EXTENSION'S EXIT POINT TO THE DEPTH OF THE ANCHOR. THE PATIENT HAS ALSO SEVERE SEPSIS. THE PATIENT WAS HOSPITALIZED, RECEIVED IV ANTIBIOTICS AND HAD THE DEVICE EXPLANTED; THE TRIAL WAS ABORTED. ACCORDING TO THE DOCTOR, HIS ADVANCED AGE AND SEVERE DIABETES CONTRIBUTED TO THE EVENT. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 20412447 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CEREBROSPINAL FLUID LEAK. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT HAD THE LEADS EXPLANTED, THE BATTERY IS STILL IMPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 20280542 ↗
• InjurySep 20, 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 LEAD INCISION SITE. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION WAS DEVICE-RELATED. THE PATIENT RECEIVED ORAL AND IV ANTIBIOTICS AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20271342 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NAUSEA AND VOMITING DURING THE TRIAL. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE TRIAL WAS TERMINATED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Nausea; Vomiting

  MAUDE report 20212752 ↗
• InjuryAug 14, 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 LEAD INCISION SITE. THE DOCTOR DOES NOT BELIEVE THE INFECTION WAS DEVICE-RELATED. THE PATIENT HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19983015 ↗
• InjuryJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN EROSION. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Skin Erosion

  MAUDE report 19684583 ↗
• MalfunctionApr 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT ALLEGED LEAD DETACHED FROM IPG WITHIN BODY. 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: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 19149548 ↗
• InjuryApr 18, 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 LEAD INCISION SITE. THE PATIENT HAD THE DEVICE EXPLANTED. THE HCP DOES NOT BELIEVE THE INFECTION WAS DEVICE-RELATED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19130367 ↗
• InjuryMar 11, 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 LEAD SITE. AN HCP ASSESSMENT REGARDING THE CAUSE OF INFECTION WAS NOT AVAILABLE. THE PATIENT HAD ORAL ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18875377 ↗
• MalfunctionMar 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, PER RECENT X-RAYS, THAT ONE ELECTRODE FROM THE PATIENT'S LEAD IS COMPLETELY SEPARATED. 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: Foreign Body In Patient

  MAUDE report 18836789 ↗