Nevro® LEAD3005-70BRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00813426020404), received between Jan 24, 2018 and Feb 27, 2024 — classified as 17 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, PER RECENT X-RAYS, THAT THE PATIENT'S LEAD IS FRACTURED. 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: Foreign Body In Patient

  MAUDE report 18791593 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW-UP INDICATED THAT THE DEVICE WAS REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 9199684 ↗
• InjuryJan 2, 2019Adverse 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 NEW FOOT PAIN AFTER IMPLANT. THE PATIENT ALLEGED THERE WAS NERVE DAMAGE. THE IMPLANTING PHYSICIAN BELIEVES THE PAIN WAS DUE TO THE PHYSICAL PLACEMENT OF THE LEADS AND WAS NOT AWARE OF ANY NERVE DAMAGE. THE PATIENT HAD USED THE DEVICE TO RECEIVE EFFECTIVE PAIN RELIEF; HOWEVER, HAS SCHEDULED TO EXPLANT THE DEVICE.

  Patient problems: Nerve Damage; Pain

  MAUDE report 8209003 ↗
• 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 WOKE UP FROM THE IMPLANT PROCEDURE WITH NO FEELINGS IN THE LOWER EXTREMITIES. THE PHYSICIAN NOTED THAT THE PATIENT'S EPIDURAL SPACE WAS TIGHT AND RESTRICTED. THE DEVICE WAS EXPLANTED AND THE PATIENT HAD REGAINED SOME SENSATION AND MOBILITY BACK. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Paralysis

  MAUDE report 8192824 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT DURING THE IMPLANT PROCEDURE, NEUROMONITORING INDICATED SOME NEUROLOGICAL DEFICIT. THE PHYSICIAN DECIDED NOT TO IMPLANT THE LEAD AND THE PATIENT IS CURRENTLY RECOVERING. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT AND THE PHYSICIAN WILL IMPLANT THE LEAD IN THE FUTURE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 8127371 ↗
• InjuryNov 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 THE TRIAL PROCEDURE, THE PATIENT DEVELOPED PARALYSIS DUE TO AN EPIDURAL HEMATOMA. THE LEAD WAS EXPLANTED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hematoma; Paralysis

  MAUDE report 8072453 ↗
• InjuryNov 6, 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 SHORTLY AFTER THE IMPLANT PROCEDURE AND THE PATIENT EXPERIENCED PARTIAL PARALYSIS OF THE LOWER EXTREMITIES. THE LEAD WAS REMOVED OUT OF THE EPIDURAL SPACE AND PLACED INTO THE SUBCUTANEOUS TISSUE. SURGICAL DECOMPRESSION WAS PERFORMED, THE LEAD WAS PLACED BACK INTO THE EPIDURAL SPACE, AND THE PATIENT WAS TRANSFERRED TO A REHABILITATION UNIT. FOLLOW-UP INDICATED THAT THE PATIENT HAS RECOVERED AND IS CURRENTLY USING THE DEVICE WITH EFFECTIVE PAIN RELIEF.

  Patient problems: Hematoma; Paresis

  MAUDE report 8044780 ↗
• InjuryNov 6, 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 TWO DAYS AFTER THE IMPLANT PROCEDURE. THE HEMATOMA WAS DRAINED AND THE DEVICE WAS EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 8044779 ↗
• InjuryOct 23, 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 SHORTLY AFTER THE TRIAL PROCEDURE. THE PATIENT ALSO REPORTED WEAKNESS IN THE LOWER EXTREMITY. AS A CONSEQUENCE, THE LEAD WAS EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 7998042 ↗
• 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 REPORTED DISCOMFORT AT THE PADDLE INSERTION SITE. A CT SCAN REVEALED THE PADDLE WAS PRESSING ON THE CORD AS THE SPINAL CANAL WAS TOO NARROW. ALTHOUGH THE PATIENT WAS REPORTING EFFECTIVE PAIN RELIEF FROM THE DEVICE, THE PATIENT HAD THE DEVICE EXPLANTED. THE PATIENT HAS RECOVERED WITH NO SEQUELAE.

  Patient problems: Pain

  MAUDE report 7972162 ↗
• InjurySep 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT ABOUT ONE MONTH AFTER IMPLANT THE PATIENT DEVELOPED AN INFECTION AT THE LEAD INCISION SITE AND REPORTED DRAINING OF FLUID FROM THE INCISION SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND GIVEN SILVER DRESSINGS. FOLLOW-UP INDICATED THAT THE LEAD WIRES WERE EXPOSED AND THE PHYSICIAN DECIDED TO EXPLANT THE DEVICE. NEVRO ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE INFECTION BUT WAS UNSUCCESSFUL. PRIOR TO THE EXPLANT BUT THE PATIENT HAD REPORTED RECEIVING EFFECTIVE PAIN RELIEF FROM THE DEVICE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 7895778 ↗
• 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 THE IMPLANT PROCEDURE, THE PATIENT EXPERIENCED NO FEELINGS IN THE LEGS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND SUBSEQUENTLY THE LEADS WERE REMOVED. THE PHYSICIAN THINKS THERE WAS AN EPIDURAL HEMATOMA. THE PATIENT HAS RECOVERED ALL FEELINGS IN THE LEGS AND IS RECOVERING.

  Patient problems: Hematoma; Numbness

  MAUDE report 7879489 ↗
• InjuryAug 28, 2018Adverse 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 SEVERE PAIN IN THE GENITAL AREA. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS ADMINISTERED MEDICATIONS. THE PHYSICIAN INDICATED THAT THE EVENT WAS NOT RELATED TO THE DEVICE; HOWEVER, LIKELY RELATED TO THE PROCEDURE. THE PHYSICIAN ADVISED THE PATIENT TO PROCEED WITH THE TRIAL. THE PATIENT HAD A SUCCESSFUL TRIAL AND NOW HAS BEEN IMPLANTED WITH THE PERMANENT DEVICE.

  Patient problems: Pain

  MAUDE report 7822989 ↗
• InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT SHORTLY AFTER THE IMPLANT PROCEDURE THE PATIENT COULD NOT MOVE HIS LEFT LEG AND AS A RESULT, THE LEADS WERE EXPLANTED. THE PHYSICIAN BELIEVES THE SYMPTOMS WERE LIKELY RELATED TO THE PROCEDURE. FOLLOW-UP INDICATED THAT THE PATIENT IS RECOVERING AND IPG REMAINS IMPLANTED.

  Patient problems: Paralysis

  MAUDE report 7794520 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT AFTER THE IMPLANT PROCEDURE THE PATIENT EXPERIENCED PAIN AND NUMBNESS. THE PATIENT WAS GIVEN MEDICATION. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO EXPLANT THE DEVICE. THE PATIENT IS RECOVERING AND WAS REFERRED TO PHYSICAL THERAPY.

  Patient problems: Numbness; Pain

  MAUDE report 7780707 ↗
• 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 DEVELOPED AN EPIDURAL HEMATOMA AFTER THE LEAD WAS IMPLANTED. THE LEAD WAS EXPLANTED AND THE BLEEDING WAS STOPPED. THE PATIENT IS DOING WELL AND RECOVERING IN THE ICU. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 7680191 ↗
• 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 COULD NOT WALK AND WAS RECENTLY SENT HOME FROM REHABILITATION WITH MEDICATIONS FOR NERVE PAIN AND ANTI-COAGULANT. NEVRO TRIED TO OBTAIN ADDITIONAL INFORMATION HOWEVER THE CAUSE IS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT HAD AN EMERGENCY SURGERY FOR GALL BLADDER BEFORE IMPLANT. STIMULATION CONTINUES TO BE ON AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS.

  Patient problems: Neurological Deficit/Dysfunction; Thrombosis

  MAUDE report 7671050 ↗
• InjuryJan 24, 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 ACQUIRED AN INFECTION FOLLOWING AN IMPLANT PROCEDURE. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. THERE HAVE BEEN NO FURTHER REPORTS OF COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 7217579 ↗