Nevro® TLEAD1058-50BRecalls & reported problems

Summary

The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 00813426020367), received between Sep 24, 2015 and Oct 30, 2023 — classified as 6 deaths, 144 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 173 reports, in the reporter's own words as published by the FDA.

• DeathOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO AN UNKNOWN CANCER. AN HCP ASSESSMENT REGARDING THE CAUSE OF DEATH WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THE PASSING.

  Patient problems: Cancer

  MAUDE report 18035994 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT'S TRIAL WAS ABORTED DUE TO DROPPING VITAL SIGNS. THE PATIENT WAS ADMINISTERED CPR AND WAS TRANSPORTED TO HOSPITAL FOR FURTHER EVALUATION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 13625712 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LIMITED MOVEMENT OF THEIR LEFT SIDE FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT WAS RECOVERING AND REGAINING MOVEMENT, HOWEVER, THE PHYSICIAN DECIDED TO REMOVE THE DEVICE. THE PATIENT HAS CONTINUED TO RECOVER SINCE THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Dyskinesia

  MAUDE report 13518584 ↗
• MalfunctionJan 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE PHYSICIAN REMOVED THE LEAD, IT FRACTURED AND THE DISTAL END OF THE LEAD REMAINED IN THE PATIENT. THE PHYSICIAN OPTED TO LEAVE THE LEAD FRAGMENT IMPLANTED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13256302 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 13171791 ↗
• InjuryDec 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. IMAGING INDICATED THE PATIENT HAD A HEMATOMA. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hematoma; Pain

  MAUDE report 13085746 ↗
• MalfunctionDec 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE PHYSICIAN TRIED TO PLACE THE LEAD DURING THE TRIAL PROCEDURE, THE LEAD FRACTURED AND THE DISTAL END OF THE LEAD REMAINED IN THE PATIENT. THE TRIAL WAS COMPLETED SUCCESSFULLY AND THE PHYSICIAN PLANS TO REMOVE THE DETACHED PORTION OF THE LEAD AT THE TIME OF THE PERMANENT IMPLANT SURGERY. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13085744 ↗
• InjuryNov 12, 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 PROCEDURAL PAIN IN THE LOW ABDOMEN. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 12804950 ↗
• InjuryOct 26, 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 PAIN AT THE INCISION SITE, AND DISCOMFORT WHILE BREATHING. THE PHYSICIAN BELIEVED THE PATIENT WAS EXPERIENCING A REACTION TO THE DEVICE. THE PHYSICIAN REMOVED THE DEVICE AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12701040 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT ACQUIRED AN INFECTION DURING THE TRIAL. THE DEVICE WAS REMOVED AND THE PATIENT WAS GIVEN IV ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12661654 ↗
• InjuryOct 8, 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 MIGRAINE AND NECK PAIN. THE PHYSICIAN FOUND THAT THIS WAS CAUSED BY LEAKAGE OF CEREBROSPINAL FLUID. THE PATIENT WAS HOSPITALIZED DUE TO HIGH BLOOD PRESSURE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT AND THE PATIENT CONTINUED THE TRIAL TO FIND EFFECTIVE PAIN RELIEF.

  Patient problems: Cerebrospinal Fluid Leakage; Headache; High Blood Pressure/ Hypertension

  MAUDE report 12598828 ↗
• InjurySep 8, 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 POSSIBLE BLOOD CLOT IN THEIR LEFT LEG. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12443073 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW-UP INDICATED THAT THE PATIENT'S POCKET PAIN AND FEVER WERE DUE TO AN INFECTION CAUSED BY A BANDAGE CHANGED AT HOME. THE PHYSICIAN DRAINED THE INFECTION AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Fever; Pain; Unspecified Infection

  MAUDE report 12316742 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT SHORTLY AFTER THE TRIAL PROCEDURE THE PATIENT DEVELOPED PAIN AND SENSORY LOSS. THE DEVICE WAS REMOVED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL.

  Patient problems: Numbness; Pain

  MAUDE report 12301771 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT DURING THE TRIAL THE PATIENT EXPERIENCED PAIN AND TENDERNESS AT THE LEAD INCISION SITE. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT. THE TRIAL WAS SUCCESSFUL AND THE PATIENT MAY BE IMPLANTED IN THE FUTURE WITH A PERMANENT DEVICE.

  Patient problems: Pain

  MAUDE report 12298356 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT SHORTLY AFTER THE TRIAL PROCEDURE THE PATIENT EXPERIENCED PAIN IN THE RIGHT ANKLE. THERE WERE NO REPORTED ISSUES DURING THE PROCEDURE AND THE DEVICE WAS NEVER TURNED ON. THE PHYSICIAN BELIEVED IT WAS A RUBBED DERMATOME. THE LEAD WAS REMOVED AND THE PATIENT HAS RECOVERED WITHOUT SEQUELAE.

  Patient problems: Pain

  MAUDE report 12298323 ↗
• InjuryAug 5, 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 FEVER ALONG WITH BACK AND ABDOMINAL PAIN. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Fever; Pain

  MAUDE report 12285109 ↗
• MalfunctionJul 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE WAS RETURNED AND ANALYZED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12236134 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT ACQUIRED AN INFECTION AT THE INCISION SITE AND EXPERIENCED FEVER. NEVRO ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE ISSUE, BUT NONE WAS AVAILABLE. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12235851 ↗
• InjuryJul 19, 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 STROKE. THE PHYSICIAN BELIEVED THIS TO BE DUE TO THE DISCONTINUATION OF BLOOD THINNERS PRIOR TO THE PROCEDURE. THE DEVICE WAS REMOVED AND THE PATIENT REMAINS UNDER MEDICAL SUPERVISION.

  Patient problems: Transient Ischemic Attack

  MAUDE report 12194118 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT FAINTED DUE TO A REACTION TO ANESTHESIA USED DURING THE TRIAL PROCEDURE. THE PATIENT WAS HOSPITALIZED AND RECOVERED WITHOUT SEQUELAE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT AND THE PATIENT FINISHED THEIR TRIAL WITH NO FURTHER ISSUES.

  Patient problems: Syncope/Fainting

  MAUDE report 12163426 ↗
• InjuryMay 28, 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 ADMITTED TO THE HOSPITAL FOR BLOOD CLOTS. THE LEAD WAS REMOVED AND THE PATIENT WAS STARTED ON HEPARIN. THE PHYSICIAN BELIEVES THE INCIDENT WAS CAUSED BY THE PATIENT STOPPING HER BLOOD THINNERS FOR THE PROCEDURE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 11904372 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT LOST FUNCTION IN THEIR RIGHT LEG. A BRUISED SPINAL CORD WAS DIAGNOSED AND THE DEVICE WAS REMOVED. THE PATIENT IS REGAINING LEG FUNCTION AND UNDERGOING PHYSICAL THERAPY.

  Patient problems: Paralysis; Spinal Cord Injury

  MAUDE report 11887004 ↗
• InjuryMay 5, 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 A DEEP VEIN THROMBOSIS DURING THE TRIAL. THE TRIAL WAS ENDED EARLY AND THE DEVICE WAS REMOVED TO START HEPARIN THERAPY. THE PHYSICIANS DO NOT BELIEVE THE INCIDENT WAS RELATED TO THE DEVICE AND NOTED THE PATIENT HAS A HISTORY OF CLOTTING AND NEEDS TO BE ON BLOOD THINNERS LONG TERM. THE TRIAL WAS SUCCESSFUL PRIOR TO THE INCIDENT AND THE PATIENT MAY BE IMPLANTED WITH THE PERMANENT DEVICE IN THE FUTURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11780966 ↗
• InjuryApr 28, 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 A HEMATOMA SHORTLY AFTER THE TRIAL PROCEDURE. THE DEVICE WAS REMOVED AND A LAMINECTOMY WAS PERFORMED. THE PATIENT DID NOT STOP TAKING THEIR ANTICOAGULANT MEDICATION, WHICH THE PHYSICIAN BELIEVES WAS THE CAUSE OF THE HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 11739831 ↗