Surpass LEAD2005-70BRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00813426020589), received between May 7, 2021 and Apr 13, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION INDICATES THAT THE PATIENT DEVELOPED NEW-ONSET SPINAL CORD SYMPTOMS ASSOCIATED WITH A TIGHT FIT AND AN EPIDURAL HEMATOMA. SHE SUBSEQUENTLY UNDERWENT AN EXTENSION LAMINECTOMY; HOWEVER, THIS PROCEDURE DID NOT RESOLVE THE SYMPTOMS OF SPINAL CORD IMPINGEMENT. THE DEVICE WAS ULTIMATELY EXPLANTED.

  Patient problems: Hematoma; Numbness

  MAUDE report 24859749 ↗
• InjuryMar 31, 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 24747139 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PARALYSIS AND DEVELOPED AN EPIDURAL HEMATOMA. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE CAUSE OF THESE SYMPTOMS WAS NOT AVAILABLE. THE DEVICE WAS SUBSEQUENTLY REMOVED. NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: Hematoma; Paralysis

  MAUDE report 24562615 ↗
• MalfunctionSep 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SCANS THE PATIENT WAS HAVING DUE TO AN UNRELATED CAR ACCIDENT, SOMEONE MENTIONED A BROKEN WIRE. 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 23098044 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED CONFIRMS THAT THE PATIENT ALSO DEVELOPED AN INFECTION AND WAS TREATED WITH IV ANTIBIOTICS. THE INFECTION RESOLVED IN (B)(6) 2025, PER THE INFECTIOUS DISEASE PHYSICIAN.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 22671508 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN STAPH INFECTION AT THE LEAD INCISION SITE APPROX. 1 WEEK AFTER IMPLANT. THE PATIENT RECEIVED ORAL ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 20553863 ↗
• InjuryOct 23, 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 TWO ROUNDS OF ORAL ANTIBIOTICS AND IS IMPROVING. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20517911 ↗
• InjurySep 24, 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. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20293449 ↗
• InjurySep 23, 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. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20287533 ↗
• InjuryMar 28, 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 WOUND HEALING ISSUE IS DEVICE RELATED. THERE WAS A CULTURE DONE DURING THE TIME OF FLUID REMOVAL AND IT DID COME BACK POSITIVE. THE PATIENT HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Bacterial Infection; Cerebrospinal Fluid Leakage

  MAUDE report 18992022 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN POST-PROCEDURE. THE SURGEON BELIEVES THE PADDLE THAT WAS USED WAS TOO BIG. THE SYSTEM WAS EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Abdominal Pain

  MAUDE report 18707499 ↗
• InjuryJan 29, 2024Adverse 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. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT'S LEAD WAS REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Impaired Healing; Implant Pain

  MAUDE report 18603021 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PARALYSIS AFTER THE PROCEDURE. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT WAS EXPLANTED AND HER FEELING IS COMING BACK SLOWLY. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Paralysis

  MAUDE report 18069932 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEMATOMA. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 17083396 ↗
• InjuryMay 18, 2023Adverse 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. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT WAS HOSPITALIZED AND THE SYSTEM WAS REMOVED, THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16953423 ↗
• InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEAD REVISION FOR INADEQUATE PAIN RELIEF. DURING RECOVERY, THE PATIENT HERNIATED THEIR DISC AT THE LEVEL OF THE ELECTRODES DUE TO CONVULSIONS AND VOMITING FROM ANESTHESIA. THE PATIENT THEN EXPERIENCED NUMBNESS AND PARTIAL PARALYSIS IN THEIR LEFT LEG. THE PATIENT WAS HOSPITALIZED. THE LEAD WAS REMOVED AND THE PATIENT WAS IN REHABILITATION. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Inadequate Pain Relief; Intervertebral Disc Compression or Protrusion; Numbness; Paralysis

  MAUDE report 16448994 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT LOST SENSATION AND MOTOR FUNCTION OF THE LOWER EXTREMITIES FOLLOWING THE IMPLANT PROCEDURE. THE DEVICE WAS LATER REMOVED AND THE PATIENT IS REGAINING FUNCTION AND MOVEMENT OF THEIR LEGS AND REMAINS UNDER MEDICAL SUPERVISION.

  Patient problems: Paralysis

  MAUDE report 15844393 ↗
• InjuryOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT EXPERIENCED A DURA LEAK DURING THE IMPLANT PROCEDURE. THE PHYSICIAN CHOSE TO ABORT THE PROCEDURE AND THE DURA LEAK RESOLVED ON ITS OWN. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 12605676 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT DEVELOPED LEAKAGE OF CEREBROSPINAL FLUID. A BLOOD PATCH WAS ADMINISTERED AND THE PATIENT WAS HOSPITALIZED. THE PATIENT HAS RECOVERED AND IS CURRENTLY USING THEIR DEVICE TO FIND EFFECTIVE PAIN RELIEF.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 12166947 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT WAS HOSPITALIZED FOR AN INFECTION. THE INFECTION WAS CLEANED OUT AND THE PATIENT WAS GIVEN ANTIBIOTICS. NEVRO ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE INFECTION BUT WAS UNSUCCESSFUL. THE PATIENT HAS RECOVERED WITHOUT SEQUELAE AND IS CURRENTLY USING THEIR DEVICE WITH EFFECTIVE PAIN RELIEF.

  Patient problems: Unspecified Infection

  MAUDE report 11793420 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT EXPERIENCED CONTINUAL LEAKAGE OF CEREBROSPINAL FLUID AND AN INFECTION. THE DEVICE WAS REMOVED AND THE LEAK WAS REPAIRED. THE PATIENT IS RECOVERING IN THE HOSPITAL.

  Patient problems: Cerebrospinal Fluid Leakage; Unspecified Infection

  MAUDE report 11793274 ↗