Nevro® TLEAD1058-70BRecalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00813426020374), received between Apr 25, 2016 and Aug 11, 2022 — classified as 50 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION, AS A RESULT OF WHICH THE PATIENT WAS HOSPITALIZED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION, BUT NONE WAS AVAILABLE. THE PATIENT HAS BEEN SCHEDULED TO BE DISCHARGED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15214558 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING INCREASED PAIN SINCE THE END OF THE TRIAL. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE ISSUE, BUT NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Pain

  MAUDE report 14606926 ↗
• InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DECREASED SENSATION AND FUNCTION OF BILATERAL LEGS. THE PHYSICIAN REMOVED THE DEVICE AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN BELIEVED THE PATIENT SUFFERED A SPINAL CORD INJURY DURING THE PROCEDURE. THE PATIENT HAS SINCE BEEN TRANSFERRED TO A REHABILITATION FACILITY AND IS IMPROVING.

  Patient problems: Paralysis; Spinal Cord Injury

  MAUDE report 14527083 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED FEVER, VOMITING, AND MIGRAINES. THE PHYSICIAN BELIEVED THIS WAS CAUSED BY A POSSIBLE LEAKAGE OF CEREBROSPINAL FLUID AND THAT THE DURA MAY HAVE BEEN PUNCTURED DURING LEAD PLACEMENT. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 13253001 ↗
• MalfunctionDec 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE PHYSICIAN TRIED TO REMOVE THE LEAD AT THE END OF THE TRIAL, THE DISTAL END OF THE LEAD REMAINED IN THE PATIENT. THE DETACHED PORTION WAS LATER SURGICALLY REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12989982 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING WOUND HEALING ISSUE AT THE INSERTION SITE. THE PHYSICIAN DECIDED TO END THE TRIAL AND REMOVED THE LEADS. THE PATIENT WAS PROVIDED ORAL ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Impaired Healing

  MAUDE report 12921389 ↗
• 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 LEAKAGE OF CEREBROSPINAL FLUID. THE PATIENT WAS HOSPITALIZED AND SCHEDULED FOR A BLOOD PATCH. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 12598847 ↗
• InjurySep 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 KNEE PAIN DURING THE TRIAL. THE DEVICE WAS REMOVED AND THE PATIENT WAS GIVEN PAIN MEDICATION. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 12435990 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT AFTER THE TRIAL THE PATIENT DEVELOPED AN INFECTION. NEVRO ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE INFECTION BUT WAS UNSUCCESSFUL. THE PATIENT WAS GIVEN ANTIBIOTICS AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12298283 ↗
• 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 DURING THE TRIAL THE PATIENT DEVELOPED SYMPTOMS FROM A LEAKAGE OF CEREBROSPINAL FLUID. THE DEVICE WAS REMOVED AND THE PATIENT LATER HAD A BLOOD PATCH TO RESOLVE THE ISSUE. THE PATIENT HAS RECOVERED WITHOUT SEQUELAE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 12285224 ↗
• 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 DEVELOPED ARM AND HAND PAIN DURING THE TRIAL. SYMPTOMS IMPROVED WHEN STIMULATION WAS TURNED OFF. THE PATIENT ATTEMPTED TO CONTINUE THE TRIAL BUT ULTIMATELY THE DEVICE WAS REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 12194148 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT DURING POST-OP OF THE TRIAL PROCEDURE, THE PATIENT HAD SENSATION ISSUES WITH THEIR LEFT LEG. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Numbness

  MAUDE report 12097107 ↗
• InjuryMay 24, 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 PROCEDURE, THE PATIENT EXPERIENCED WEAKNESS IN THE LEFT LEG. THIS OCCURRED WHEN THE PHYSICIAN ADVANCED THE INSERTION NEEDLE TOO FAR. THE PROCEDURE WAS STOPPED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 11872269 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION INDICATED THAT THE PATIENT ACQUIRED AN INFECTION WHICH WAS CONFIRMED TO BE MENINGITIS. PER THE PHYSICIAN, THE MENINGITIS IS NOT DEVICE RELATED.

  Patient problems: Fever

  MAUDE report 11793719 ↗
• 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 PARESTHESIA IN THE ARMS AND CHEST. THE ISSUE WAS RESOLVED BY ENDING THE TRIAL EARLY AND REMOVING THE LEADS. THE PATIENT HAD A SUCCESSFUL TRIAL PRIOR TO THE INCIDENT AND IS WAITING TO BE IMPLANTED WITH THE PERMANENT DEVICE.

  Patient problems: Paresthesia

  MAUDE report 11780957 ↗
• 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 EXPERIENCED IRRITATION FROM THE SURGICAL TAPE AROUND THE INCISION SITE. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 11780276 ↗
• InjuryMar 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 LEAKAGE OF CEREBROSPINAL FLUID. THE PHYSICIAN APPLIED A BLOOD PATCH AND REMOVED THE DEVICE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 11429848 ↗
• MalfunctionJan 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO NEVRO THAT DURING THE TRIAL PROCEDURE, THE LEAD TIP DETACHED DURING INSERTION. THE INCIDENT MAY HAVE BEEN DUE TO USER ERROR WHEN THE INSERTION WAS TOO STEEP. THE PHYSICIAN IS NOT CONCERNED ABOUT THE FRAGMENT IN THE BODY, AND WILL REMOVE THE FRAGMENT DURING A FUTURE BACK SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11143850 ↗
• InjuryDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT EXPERIENCED NUMBNESS AND BOWEL ISSUES. THE DEVICE WAS REMOVED AND THE PATIENT REMAINS UNDER MEDICAL SUPERVISION.

  Patient problems: Constipation; Numbness

  MAUDE report 10955532 ↗
• 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 WENT INTO CARDIAC ARREST DURING THE TRIAL PROCEDURE. THE PROCEDURE WAS STOPPED, THE DEVICE WAS REMOVED, AND THE PATIENT WAS HOSPITALIZED

  Patient problems: Cardiac Arrest

  MAUDE report 10736730 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT AFTER A SUCCESSFUL TRIAL, THE PATIENT DEVELOPED AN INFECTION. NEVRO ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE INFECTION BUT WAS UNSUCCESSFUL. THE PATIENT WAS HOSPITALIZED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT. THE PATIENT WILL HAVE THE PERMANENT IMPLANT IN THE FUTURE.

  Patient problems: Unspecified Infection

  MAUDE report 10638350 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT EXPERIENCED LEAKAGE OF CEREBROSPINAL FLUID AND SPINAL HEADACHES FOLLOWING THE TRIAL PROCEDURE. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 10583930 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT AFTER THE TRIAL PROCEDURE, THE PATIENT WAS UNABLE TO LIFT THEIR RIGHT LEG AND WAS FALLING. 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: Neurological Deficit/Dysfunction

  MAUDE report 10474208 ↗
• InjuryAug 13, 2020Adverse 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 DUE TO PAIN IN THE RIGHT LEG FOLLOWING THE TRIAL PROCEDURE. THE LEADS WERE REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT

  Patient problems: Pain

  MAUDE report 10403650 ↗
• InjuryJul 1, 2020Adverse 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 LEAD SITE, UPPER THORACIC AREA AND DOWN THEIR ARMS AND LEGS. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 10221083 ↗