Surpass LEAD2005-90BRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00813426020640), received between Feb 10, 2021 and May 5, 2026 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BURNING PAIN, SPORADIC ELECTRICAL SHOCKING SENSATIONS, NUMBNESS, AND WEAKNESS IN HIS LOWER EXTREMITIES. THE PATIENT REPORTS SUSTAINING WORSENING NEUROLOGICAL INJURY THE LONGER THE LEADS WERE IMPLANTED THE MORE SEVERE AND PERMANENT THE NERVE DAMAGE BECAME. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE.

  Patient problems: Muscle Weakness/Atrophy; Nerve Damage; Numbness; Pain

  MAUDE report 25086786 ↗
• InjuryOct 21, 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 AT THE LEAD INCISION SITE. THE PATIENT RECEIVED ORAL ANTIBIOTICS AND NO LONGER HAS INFECTION. IT WAS NOT DEVICE RELATED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 23352756 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING SENSATIONS AT THE LEAD SITE. 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: Pain

  MAUDE report 21921121 ↗
• MalfunctionNov 26, 2024Fracture; Fracture

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION AND IT WAS FOUND THERE WAS THE WHITE WIRE BROKEN FROM THE PADDLE WHILE IT WAS IMPLANTED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20779880 ↗
• InjuryJul 17, 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 IV ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19763928 ↗
• InjuryApr 30, 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 POCKET AND LEAD SITE. AN HCP ASSESSMENT REGARDING THE CAUSE OF INFECTION WAS NOT AVAILABLE. THE PATIENT WAS EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19211627 ↗
• InjuryMar 13, 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 PADDLE SITE DURING A TRIAL. DR. (B)(6) FELT THERE WAS NO INFECTION AND NO CULTURES WERE TAKEN, THE DOCTOR DOES NOT THINK ANY NEVRO PRODUCTS WERE RESPONSIBLE FOR ANY NEGATIVE OUTCOMES. THE PATIENT WAS HOSPITALIZED, 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 18896187 ↗
• InjuryMar 4, 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. THE PHYSICIAN DOES NOT BELIEVE IT WAS DEVICE RELATED. THE PATIENT HAD WOUND WASHOUT, ORAL AND IV ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18832635 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PARALYSIS ON THEIR LEFT SIDE CHARACTERIZED BY A LOSS OF STRENGTH IN THE LEFT ARM AND AN INABILITY TO WALK, AS WELL AS BLADDER RETENTION FOLLOWING IMPLANT PROCEDURE. THE PHYSICIAN IS UNCERTAIN ABOUT THE CAUSE OF THE REPORTED ISSUES. PATIENT WAS TREATED WITH IV MEDICATION AND REHABILITATION. ADDITIONALLY, THE DEVICE WAS REPLACED. FOLLOWING THIS REPLACEMENT PROCEDURE, THE PATIENT EXPRESSED A DESIRE TO HAVE THE IMPLANTED DEVICES REMOVED. THE DEVICES WERE REMOVED. THE PHYSICIAN HAS CONFIRMED THAT THE PATIENT IS CURRENTLY RECOVERING AND HAS REGAINED STRENGTH AND SENSITIVITY. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Paralysis; Urinary Retention

  MAUDE report 17674617 ↗
• MalfunctionAug 1, 2023Break; Break

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF AND PAIN AT THE LEAD AREA. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE DEVICE WAS REMOVED AND IT WAS OBSERVED THAT SOME OF THE LEAD WIRES WERE EXPOSED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Implant Pain; Inadequate Pain Relief

  MAUDE report 17438467 ↗
• InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE REPORTED SYMPTOM WAS NOT AVAILABLE. THE PATIENT'S LEAD WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 16976131 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE NUMBNESS IN THEIR ARMS AND HANDS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN REGARDING THE NATURE OF THE NUMBNESS, BUT NONE WAS AVAILABLE. THE PATIENT WAS HOSPITALIZED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Numbness; Pain

  MAUDE report 16139441 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBROSPINAL FLUID LEAK. TO RESOLVE THE ISSUE, THE DURA MATER WAS SUTURED AND THE AREA WAS PATCHED WITH TACHOSIL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 15252200 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE INCISION SITE. NEVRO ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE INFECTION BUT WAS UNSUCCESSFUL. ANTIBIOTICS WERE GIVEN AND THE PATIENT IS RECOVERING. THE DEVICE IS CURRENTLY BEING USED WITH EFFECTIVE PAIN RELIEF.

  Patient problems: Unspecified Infection

  MAUDE report 11311791 ↗