Nevro® LEAD3005-50BRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00813426020398), received between Feb 5, 2018 and Dec 21, 2018 — classified as 20 injuries.

The most frequently reported specific device problem is “Difficult To Position” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2018Adverse 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 STOMACH PAIN AFTER A LEAD REVISION PROCEDURE. THE PATIENT ADDITIONALLY REPORTED APPETITE ISSUES, CONSTIPATION AND NECK SWELLING. THE PATIENT HAS RECOVERED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT. THE PATIENT IS CURRENTLY USING THEIR DEVICE TO FIND EFFECTIVE PAIN RELIEF.

  Patient problems: Pain

  MAUDE report 8192827 ↗
• InjuryDec 21, 2018Adverse 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. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND A LUMBAR DRAIN WAS PLACED. FOLLOW-UP INDICATED THAT THE PATIENT HAS RECOVERED AND IS CURRENTLY USING THE DEVICE TO FIND EFFECTIVE PAIN RELIEF. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 8192765 ↗
• InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT DEVELOPED AN INFECTION AND WOUND DEHISCENCE. NEVRO ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE INFECTION BUT WAS UNSUCCESSFUL. THE DEVICE WAS EXPLANTED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 8097804 ↗
• InjuryOct 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT DURING A SURGICAL LEAD IMPLANT, NEUROMONITORING INDICATED SOME NEUROLOGICAL DEFICIT IN THE LEGS. THE PHYSICIAN REMOVED THE LEAD AND THE PATIENT RETURNED TO BASELINE ACTIVITY. AFTER THE PROCEDURE, THE PATIENT REPORTED PAIN AND SORENESS AND WILL FOLLOW-UP WITH HER PHYSICIAN. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Neurological Deficit/Dysfunction; Pain

  MAUDE report 7972161 ↗
• InjuryOct 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT WENT TO A REHABILITATION FACILITY AFTER THE IMPLANT PROCEDURE DUE TO POST-OP PAIN. THE PHYSICIAN BELIEVED THE SYMPTOMS WERE DUE TO THE PATIENT'S PRE-EXISTING CONDITION AND FROM THE PROCEDURE. FOLLOW-UP INDICATED THAT THE PATIENT IS USING THE DEVICE TO FIND EFFECTIVE THERAPY AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 7972159 ↗
• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT DEVELOPED RIB PAIN AND IRRITABLE BOWEL SYNDROME (IBS) SYMPTOMS AFTER IMPLANT. PATIENT CONTINUED TO EXPERIENCE THESE SYMPTOMS EVEN WHEN THE DEVICE WAS TURNED OFF AND THE PATIENT HAD A HISTORY OF IBS SYMPTOMS. THE DEVICE WAS EXPLANTED AS A RESULT OF THESE SYMPTOMS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 7954635 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT ACQUIRED A SLIGHT INFECTION DURING THE TRIAL. AS A CONSEQUENCE, THE PATIENT WENT TO THE ER AND WAS GIVEN ORAL ANTIBIOTICS. THE FOLLOWING DAY, THE PATIENT PROCEEDED WITH THE PERMANENT IMPLANT SINCE THE TRIAL WAS SUCCESSFUL. DURING THE IMPLANT PROCEDURE, PURULENT DRAINAGE WAS FOUND. AS A RESULT, THE DEVICE WAS EXPLANTED. NEVRO ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE INFECTION BUT WAS UNSUCCESSFUL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7928408 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT A FEW DAYS AFTER THE IMPLANT PROCEDURE, THE PATIENT DEVELOPED TEMPORARY PARALYSIS IN THE LEGS. THE PATIENT WAS HOSPITALIZED AND SUBSEQUENTLY THE PHYSICIAN EXPLANTED ONLY THE LEAD. DURING EXPLANT THE PHYSICIAN FOUND AN EPIDURAL HEMATOMA. THE PATIENT WAS DOING PHYSICAL THERAPY AND REGAINING MOVEMENT IN THE LEGS. FOLLOW-UP INDICATED THAT THE PATIENT WAS DISCHARGED HOME AND IS ABLE TO WALK WITH A WALKER.

  Patient problems: Hematoma; Paralysis

  MAUDE report 7904288 ↗
• InjurySep 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT SHORTLY AFTER A LEAD REVISION, THE PATIENT EXPERIENCED A BURNING STOMACH PAIN. AS A CONSEQUENCE, THE PATIENT WAS ADMITTED TO THE HOSPITAL. NOTES FROM THE PROCEDURE DID NOT INDICATE ANY INCIDENTS, BUT THE PHYSICIAN SPECULATED THERE MAY HAVE BEEN PRESSURE ON THE SPINAL CORD. FOLLOW-UP INDICATED THAT THE PATIENT IS CURRENTLY USING THE DEVICE TO FIND EFFECTIVE THERAPY.

  Patient problems: Pain

  MAUDE report 7879488 ↗
• InjuryAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORT TO NEVRO THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN COULD NOT ADVANCE THE LEAD DUE TO THE PATIENT'S ANATOMY AND THE PHYSICIAN ACCIDENTALLY NICKED THE DURA. AS A CONSEQUENCE, A HEMOSTATIC MATRIX WAS USED AND THE IMPLANT PROCEDURE WAS DISCONTINUED. THE PATIENT HAS RECOVERED WITHOUT SEQUELAE AND WILL PROCEED WITH THE IMPLANT PROCEDURE IN A FEW WEEKS.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 7765795 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT'S DEVICE WAS EXPLANTED DUE TO AN EPIDURAL HEMATOMA. ADDITIONALLY, THE PATIENT REPORTED LOSS OF SENSATION OF THE LOWER LIMBS AND THEREFORE WAS SENT TO A REHABILITATION FACILITY. FOLLOW-UP INDICATED THE PATIENT HAS HAD SOME LEFT LEG IMPROVEMENT AND IS UNDERGOING THERAPY TO REGAIN MORE FEELING AND MOVEMENT IN THE LEGS.

  Patient problems: Hematoma; Paralysis

  MAUDE report 7680193 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT A PATIENT WAS HOSPITALIZED DUE TO ABDOMINAL PAIN. THE PHYSICIAN EXPLANTED THE PADDLE LEAD AND RE-IMPLANTED THE PATIENT WITH PERCUTANEOUS LEADS. THE PATIENT IS DOING WELL AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS. PHYSICIAN BELIEVED THAT THE PLACEMENT OF THE PADDLE LEAD IRRITATED THE NERVE.

  Patient problems: Pain

  MAUDE report 7671051 ↗
• InjuryJul 9, 2018Adverse 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 BLOOD CLOT UNDER THE LEAD AND HAD PARTIAL PARALYSIS IN BOTH LEGS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE DEVICE WAS EXPLANTED. THE PATIENT IS RECOVERING IN REHABILITATION. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Paralysis; Thrombus

  MAUDE report 7671043 ↗
• InjuryJul 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT A CLOT FORMED AT THE LEAD SITE AND THE PATIENT DEVELOPED PARTIAL PARALYSIS OF HER LOWER EXTREMITIES. THE DEVICE WAS EXPLANTED AND THE PATIENT IS RECOVERING IN THE ICU. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Paralysis; Thrombus

  MAUDE report 7663824 ↗
• InjuryMay 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT DURING A SURGICAL LEAD IMPLANT, NEUROMONITORING INDICATED SOME ABNORMALITIES. THE PHYSICIAN REMOVED THE LEAD AND THE PATIENT REGAINED BASELINE ACTIVITY AFTER THE PROCEDURE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS. NEVRO HAD ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE ABNORMALITIES BUT WAS UNSUCCESSFUL.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 7481664 ↗
• InjuryApr 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT LOST SENSATIONS IN HER LEGS AFTER THE LEAD WAS SUCCESSFULLY PLACED. THE LEAD WAS REMOVED AND A LAMINECTOMY WAS PERFORMED. THE PATIENT IS STABLE, REGAINED ALL SENSATIONS, REPEATED THE TRIAL, AND WENT ON TO HAVE AN IPG IMPLANTED. THERE HAVE BEEN NO FURTHER REPORTS OF COMPLICATIONS.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 7401603 ↗
• InjuryApr 2, 2018Difficult To Position; Adverse Event Without Identified Device or Use Problem; Difficult To Position; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT A TRIAL PATIENT HAD LOST SENSATION IN HIS LEGS SHORTLY AFTER THE PROCEDURE. THE PHYSICIAN HAD EXPERIENCED DIFFICULTY PLACING THE LEAD. MOVEMENT IN THE LOWER EXTREMITIES WAS REGAINED IN ABOUT AN HOUR. THE PATIENT'S LEADS HAVE SUBSEQUENTLY BEEN EXPLANTED. THERE HAVE BEEN NO FURTHER REPORTS OF COMPLICATIONS.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 7390947 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT DEVELOPED AN EPIDURAL HEMATOMA. THE IMPLANTING PHYSICIAN REMOVED THE PADDLE LEAD FROM THE EPIDURAL SPACE AND DRAINED THE HEMATOMA. THE PADDLE LEAD WAS THEN PLACED UNDER THE SKIN FOR RE-IMPLANT WHEN THE PATIENT IS READY. THERE WERE NO REPORTS OF FURTHER COMPLICATIONS.

  Patient problems: Hematoma

  MAUDE report 7336545 ↗
• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT A PATIENT HAD DEVELOPED AN EPIDURAL HEMATOMA SHORTLY AFTER IMPLANT. THE NEVRO SYSTEM WAS PROMPTLY EXPLANTED. THERE HAVE BEEN NO FURTHER REPORTS OF COMPLICATIONS.

  Patient problems: Hematoma

  MAUDE report 7318020 ↗
• InjuryFeb 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT A PATIENT WAS EXPERIENCING HEADACHES. FOLLOW-UP REPORT INDICATED THAT THE HEADACHES WERE BEING CAUSED BY A CSF LEAK. THE PHYSICIAN PERFORMED A BLOOD PATCH AND THE HEADACHES HAVE IMPROVED. THE PATIENT IS CURRENTLY RECEIVING GOOD PAIN RELIEF AND THERE WERE NO REPORTS OF FURTHER COMPLICATIONS.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 7243252 ↗