Nevro® LEAD1058-90BRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00813426020053), received between Dec 14, 2015 and Feb 18, 2026 — classified as 31 injuries, 14 malfunctions.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 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: Unspecified Infection

  MAUDE report 24380626 ↗
• MalfunctionMay 28, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IMAGING REPORTEDLY SHOWED WHAT APPEARS TO BE ONE ELECTRODE DETACHED FROM THE LEAD, FLOATING NEAR THE LEAD IMPLANT SITE. THERE WAS NO REPORTED INJURY TO THE PATIENT, AND CURRENTLY, THERE ARE NO PLANS TO REVISE THE DEVICE. THE DEVICE REMAINS IMPLANTED IN SITU. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099441 ↗
• InjuryMar 24, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING SENSATION AFTER LEAD MIGRATION. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT UNDERWENT A LEAD REVISION TO ADDRESS THE ISSUE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 21674684 ↗
• InjuryFeb 5, 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 SITE. AN HCP ASSESSMENT REGARDING THE CAUSE OF 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 21316312 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN DURING THE TRIAL. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE DEVICE WAS EXPLANTED AND THE TRIAL WAS ABORTED, HOWEVER, THE PATIENT STILL REPORTS SEVERE BACK PAIN AND LACK OF RELIEF.

  Patient problems: Pain

  MAUDE report 19378157 ↗
• MalfunctionApr 9, 2024Fracture; Fracture

  PATIENT HAD HIGH IMPEDANCE MEASUREMENTS DUE TO A DEFECTIVE ELECTRODE CONTACT ON THE LEAD, NECESSITATING A DEVICE REPLACEMENT PROCEDURE. FURTHER DEVICE INVESTIGATION REVEALED THAT DAMAGED CABLES WITHIN THE LEAD WERE THE CAUSE OF THE HIGH IMPEDANCE ISSUE. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED RELATED TO THIS INCIDENT.

  Patient problems: Pain

  MAUDE report 19073988 ↗
• InjuryFeb 1, 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. AN HCP ASSESSMENT REGARDING THE CAUSE OF INFECTION WAS NOT AVAILABLE. THE PATIENT´S LEADS WERE REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18623835 ↗
• InjuryJan 10, 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 LEAD INCISION AND HAD PAIN AT LEAD INCISION. AN HCP ASSESSMENT REGARDING THE CAUSE OF INFECTION WAS NOT AVAILABLE. PATIENT WAS HOSPITALIZED, RECEIVED IV ANTIBIOTICS AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18487991 ↗
• InjuryJan 8, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAD MIGRATION AND SHOCKING SENSATION. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE HCP PERFORMED A LEAD REVISION. HOWEVER, THE LEAD MIGRATED AGAIN AND THE DEVICE WAS REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Electric Shock

  MAUDE report 18471822 ↗
• MalfunctionNov 3, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT'S LEAD WAS FRAYED. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THE DEVICE CURRENTLY REMAINS IN SITU. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066211 ↗
• MalfunctionSep 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DISTAL END TIP OF THE LEAD BECAME DETACHED. PATIENT'S COMPLEX SPINE STRUCTURE LED TO AN ABNORMAL LEAD ANGLE DURING INSERTION, RESULTING IN LEAD FRACTURE AND CONTACT DETACHMENT. UPON REMOVAL, THE PHYSICIAN NOTED THAT ELECTRODE 1 AT THE DISTAL END WAS MISSING, ALONG WITH DAMAGE TO THE OUTER CASING. THE PHYSICIAN DECIDED NOT TO PROCEED WITH THE REMOVAL OF THE ELECTRODE FROM THE PATIENT'S BODY, ASSERTING THAT THE COMPONENT IS LOCATED IN A SAFE AREA. THE IMPLANT SURGERY WAS SUCCESSFULLY COMPLETED WITH ONE LEAD. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17845755 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE LEAD SITE AFTER REVISION. 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: Pain

  MAUDE report 17145860 ↗
• MalfunctionApr 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PATIENT EXPERIENCED INCREASING NECK PAIN AND AN X-RAY SHOWED THAT THE DISTAL END OF ONE OF THE LEADS BROKE OFF. THE PHYSICIAN PLANS TO REPLACE THE PATIENT'S PERCUTANEOUS LEADS WITH A SURGICAL PADDLE. ALL PROGRAMMING WAS MOVED OVER TO THE OTHER LEAD AND THERAPY REMAINS ON. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Neck Pain

  MAUDE report 16678832 ↗
• InjuryMar 13, 2023Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT KNEE AND LOWER LEG PAIN FOLLOWING THE PROCEDURE. CT IMAGING SHOWED A LEAD HAD ROTATED THROUGH THE FORAMEN. THE PHYSICIAN DECIDED TO REMOVE THE LEAD AND THE PAIN RESOLVED POST-REMOVAL. THE PATIENT CONTINUES TO USE THERAPY WITH THE REMAINING LEAD. THE PHYSICIAN STATED THAT THE ISSUE OCCURRED LIKELY DUE TO THE PATIENT'S SCOLIOSIS AND NOT THE PRODUCT. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 16534049 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT KNEE AND LOWER LEG PAIN FOLLOWING THE PROCEDURE. CT IMAGING SHOWED A LEAD HAD ROTATED THROUGH THE FORAMEN. THE PHYSICIAN DECIDED TO REMOVE THE LEAD AND THE PAIN RESOLVED POST-REMOVAL. THE PATIENT CONTINUES TO USE THERAPY WITH THE REMAINING LEAD. THE PHYSICIAN STATED THAT THE ISSUE OCCURRED LIKELY DUE TO THE PATIENT'S SCOLIOSIS AND NOT THE PRODUCT. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 16534002 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNCOMFORTABLE SENSATIONS FROM THE CHEST DOWN TO THE LEGS. THE DEVICE WAS REMOVED AND THE SYMPTOMS HAVE SINCE IMPROVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 15965721 ↗
• MalfunctionAug 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT'S LEAD HAD FRACTURED. THE PHYSICIAN DETERMINED THAT THE FRACTURED LEAD IS NOT CAUSING ANY HARM OR DISCOMFORT TO THE PATIENT, AND THE PATIENT HAS BEEN REFERRED FOR A FUTURE PROCEDURE TO REMOVE THE FRACTURED LEAD. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15214153 ↗
• MalfunctionJul 14, 2022Break; Entrapment of Device; Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn

  IT WAS REPORTED THAT A LEAD ELECTRODE WAS SHEARED OFF DURING THE IMPLANT PROCEDURE. THE PHYSICIAN MADE THE DETERMINATION TO LEAVE THE ELECTRODE IN THE PATIENT'S BODY. THE REMAINING PORTION OF THE LEAD WAS REMOVED AND A REPLACEMENT LEAD WAS IMPLANTED SUCCESSFULLY. THE PATIENT CONTINUES TO USE THE DEVICE TO FIND EFFECTIVE PAIN RELIEF AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15019472 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A CEREBROSPINAL FLUID (CSF) LEAK AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT UNDERWENT TWO BLOOD PATCH PROCEDURES TO RESOLVE THE CSF LEAK. THE CSF LEAK RESOLVED AFTER THE SECOND BLOOD PATCH AND THE PATIENT IS CURRENTLY USING THE DEVICE TO FIND EFFECTIVE PAIN RELIEF.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 14776923 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEADACHES WHEN THE STIMULATION WAS TURNED ON. THERE WAS ALSO A REPORT OF A CEREBROSPINAL FLUID LEAKAGE THAT RESOLVED ON ITS OWN. THE PHYSICIAN DECIDED TO REMOVE THE DEVICE AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 12334703 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT DURING A LEAD REVISION THE PATIENT EXPERIENCED LEAKAGE OF CEREBROSPINAL FLUID. THE LEAKAGE WAS REPAIRED AND THE PROCEDURE WAS ABORTED WITH ONE LEAD IMPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT AND THE PATIENT IS CURRENTLY USING THEIR DEVICE TO FIND EFFECTIVE PAIN RELIEF.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 11396289 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT DEVELOPED AN ISSUE WITH NEUROMONITORING DURING THE IMPLANT PROCEDURE. THE PHYSICIAN CHOSE TO ABORT THE PROCEDURE AND THE PATIENT WAS SUCCESSFULLY IMPLANTED AT A LATER DATE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 11069778 ↗
• InjuryNov 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PHYSICIAN WAS UNABLE TO COMPLETE THE IMPLANT PROCEDURE DUE TO SCAR TISSUE. THE PATIENT EXPERIENCED LEAKAGE OF CEREBROSPINAL FLUID FOLLOWING THE PROCEDURE. THE PATIENT WAS HOSPITALIZED AND REMAINS UNDER MEDICAL SUPERVISION. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 10923486 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT DEVELOPED PAIN DUE TO THE LEADS PRESSING ON A NERVE ROOT. THE DEVICE WAS REMOVED AND THE PATIENT WILL BE SCHEDULED FOR SURGICAL PADDLE LEAD IN THE FUTURE.

  Patient problems: Pain

  MAUDE report 10736909 ↗
• MalfunctionDec 10, 2019Fracture; Fracture

  IT WAS REPORTED TO NEVRO THAT THE MOST DISTAL ELECTRODE ON THE LEAD BROKE OFF IN THE PATIENT DURING THE IMPLANT PROCEDURE. THE PATIENT DID NOT SUSTAIN ANY INJURIES. THE ELECTRODE WAS LEFT IN THE SUBCUTANEOUS TISSUE AND THE PHYSICIAN DID NOT NOTE ANY CONCERNS OR PLANS TO REMOVE THE ELECTRODE. THE PROCEDURE COMPLETED WITHOUT FURTHER COMPLICATIONS AND THE PATIENT IS CURRENTLY USING THEIR DEVICE TO FIND EFFECTIVE PAIN RELIEF.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9446029 ↗