Nevro® LEAD1058-50BRecalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 00813426020022), received between Oct 5, 2015 and Oct 20, 2025 — classified as 2 deaths, 116 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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 145 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 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 DEVELOPED AN INFECTION. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE SPECIFIC NATURE OF THE INFECTION WAS NOT AVAILABLE AT THE TIME OF REPORTING. THE PATIENT WAS HOSPITALIZED AND TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS. IN ADDITION, THEY UNDERWENT DEBRIDEMENT OF AN ABSCESS, AND THE DEVICE WAS REMOVED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED FOLLOWING THIS EVENT.

  Patient problems: Abscess; Insufficient Information; Unspecified Infection

  MAUDE report 23341363 ↗
• InjurySep 9, 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 AFTER A SPINE SURGERY. ACCORDING TO THE HCP, THE ISSUE WAS NOT RELATED TO THE DEVICE. THE PATIENT WAS 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 23001347 ↗
• InjuryJul 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 ACQUIRED AN INFECTION IN HER SPINE. 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 22663863 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EPIDURAL ABSCESS. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. IT WAS NOT MENTIONED THAT THE EVENT IS RELATED TO THE DEVICE. THE PATIENT HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Abscess

  MAUDE report 22215713 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN, WHICH WAS ATTRIBUTED TO NERVE ROOT IRRITATION CAUSED BY THE LEAD. THE PATIENT HAD THE LEAD REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 21977259 ↗
• InjuryJan 23, 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 INCISION SITE. THE PATIENT RECEIVED ORAL ANTIBIOTICS AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21222993 ↗
• InjuryDec 12, 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 WAS HOSPITALIZED AND RECEIVED ORAL ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 20921285 ↗
• MalfunctionNov 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN MRI TECHNICIAN REPORTED A FAILED IMPEDANCE CHECK, CONFIRMED BY HEARING FOUR SHORT BEEPS AFTER MULTIPLE ATTEMPTS. FURTHER INVESTIGATION REVEALED THE PATIENT HAS A SINGLE PERC LEAD WITH ELECTRODE # 3 OUT OF ACCEPTABLE RANGE. A FRACTURE WAS CONFIRMED ON HIS LEAD. 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 20739489 ↗
• MalfunctionNov 4, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN AN HCP DID AN X-RAY IT WAS FOUND BROKEN LEADS. 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 20605682 ↗
• MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE EXPLANTING PHYSICIAN THAT TWO CONTACTS WERE MISSING WHEN THE LEADS WERE TAKEN OUT THE PATIENT. 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 20353610 ↗
• InjuryAug 5, 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 RECEIVED ORAL ANTIBIOTICS AND THE ELECTRODES WERE REMOVED DURING THE DEVICE SURGERY AFTER IT WAS DISCOVERED THAT THE WOUND HAD BECOME INFECTED. THE ELECTRODES THEMSELVES WERE NOT INFECTED AND WERE ONLY REMOVED FOR SAFETY REASONS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19913402 ↗
• MalfunctionJul 22, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT'S LEADS ARE BROKEN. THE PATIENT REPORTED HE HAS FALLEN SEVERAL TIMES DUE TO HAVING SO MUCH PAIN IN HIS LOWER BACK AND LEGS THAT HE WAS HAVING BALANCE ISSUES. THE PATIENT MOSTLY USES A WHEEL CHAIR NOW. THE DOCTOR PERFORMED X-RAYS AND REPORTED THE BROKEN LEADS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Balance Problems; Fall; Inadequate Pain Relief; Pain

  MAUDE report 19794751 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD AN INFECTION AND THE LEADS WERE STICKING OUT. THE PATIENT HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Impaired Healing; Skin Erosion; Unspecified Infection

  MAUDE report 19536790 ↗
• MalfunctionFeb 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING REVISION SURGERY THE PATIENT'S LEADS WERE FRACTURED. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT'S FULL SYSTEM WAS EXPLANTED AND REPLACED BECAUSE OF THIS ISSUE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18791618 ↗
• MalfunctionFeb 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT HAD A LEAD BROKEN WHILE REMOVING THE DEVICE DUE TO AN MRI. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE ARE NO FRAGMENTS IN THE EPIDURAL BUT THE SOFT TISSUE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784720 ↗
• MalfunctionDec 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT LEAD BROKE INTO 2 DISTINCT PIECES. 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 18414970 ↗
• MalfunctionDec 6, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE HCP PERFORMED A LEAD REVISION TO CORRECT THE ORIGINAL IMPLANTED LEAD THAT WAS LEFT OUTSIDE OF EPIDURAL SPACE. DURING THE CASE, THE HCP STATED HE FELT HE COULDN'T FULLY REMOVE THE OLD LEAD BECAUSE HE FELT HE WOULD¿VE DAMAGED THE GOOD LEAD BY PULLING IT OUT. THE HCP CUT THE ELECTRODES OFF OF BOTH SIDES OF THE LEAD AND THE LEAD WAS LEFT IN THE PATIENT. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18279782 ↗
• MalfunctionOct 26, 2023Material Frayed; Insufficient Device Problem Information; Material Frayed; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A FRAYED LEAD INSULATION NEAR THE IPG CONNECTION END OF THE LEAD. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE DEVICE WAS REPLACED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014580 ↗
• MalfunctionOct 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A FRAYED LEAD INSULATION NEAR THE IPG CONNECTION END OF THE LEAD. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE DEVICE WAS REPLACED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014336 ↗
• InjurySep 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH VOLUNTARY MEDWATCH MW5119976 THAT THE PATIENT HAS EXPERIENCED INCREASING THORACIC PAIN FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT HAS BEEN TREATED WITH IV MORPHINE, NERVE BLOCKS, EPIDURAL INJECTIONS AND A LEAD WAS REMOVED TO ATTEMPT TO RESOLVE THE PAIN. THE PATIENT SINCE CONTINUES TO USE THE DEVICE AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 17676544 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND HEALING COMPLICATIONS AT THE LEAD INCISION SITE. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE REPORTED SYMPTOMS WAS NOT AVAILABLE. THE INCISION SITE WAS DRAINED, AND THE PATIENT WILL BE SCHEDULED FOR A DEVICE REMOVAL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Impaired Healing

  MAUDE report 17241108 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED DUE TO WOUND DEHISCENSE AT THE LEAD INCISION, AND INFECTION AT THE POCKET AND LEAD INCISION SITES. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTIONS AND WOUND HEALING ISSUES WAS NOT AVAILABLE. THE DEVICES WERE REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 16867935 ↗
• InjuryApr 24, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING SENSATIONS AND LEAD MIGRATION. THE PHYSICIAN BELIEVED THE SHOCKING SENSATIONS WERE DEVICE RELATED. THE PATIENT WAS HOSPITALIZED. THE PERCUTANEOUS LEADS WERE REPLACED WITH A PADDLE LEAD AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 16802428 ↗
• InjuryMar 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION INDICATED THAT : "THE LEAD WAS EXPLANTED ON (B)(6) 2023 AND IS NOT AVAILABLE FOR RETURN."

  Patient problems: Hematoma

  MAUDE report 16600466 ↗
• MalfunctionFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S TOP LEAD CONTACT IS APPROXIMATELY AT A 90 DEGREE ANGLE AND IS POSSIBLY FRACTURED. THE PHYSICIAN BELIEVES THIS WAS LIKELY CAUSED BY A FALL INVOLVING IMPACT TO THE NECK. THE PHYSICIAN DOES NOT BELIEVE THIS IS CAUSING THE PATIENT NECK PAIN AND IS NOT PLANNING ANY SURGICAL INTERVENTION. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Fall

  MAUDE report 16358631 ↗