Nevro® MADP2008-25BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813426020107), received between Jan 24, 2018 and Apr 20, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET PAIN AT THE M8 ADAPTER AREA. AN HCP ASSESSMENT REGARDING THE NATURE OF THE PAIN WAS NOT AVAILABLE. THE M8 ADAPTER AND IPG WERE REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Implant Pain

  MAUDE report 16777982 ↗
• MalfunctionJul 30, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO NEVRO THAT A FRACTURED ADAPTER WAS FOUND DURING A REVISION PROCEDURE. THE PATIENT WAS NOT INJURED. THE DEVICE WAS REPLACED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10347354 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT RECEIVED A BLOOD PATCH DUE TO A SUSPECTED LEAKAGE OF CEREBROSPINAL FLUID. THE PATIENT HAD BEEN EXPERIENCING HEADACHES, HOWEVER, THESE SYMPTOMS WERE NOTED TO BE PRE-EXISTING AND PRESENT PRIOR TO IMPLANT. NEVRO ATTEMPTED TO OBTAIN A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE SYMPTOMS BUT WAS UNSUCCESSFUL. THERE WERE NO REPORTED DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THIS INCIDENT AND THE PATIENT CONTINUES TO USE THE DEVICE TO FIND EFFECTIVE PAIN RELIEF.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 8262918 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT A PATIENT PRESENTED TO THE HOSPITAL DUE TO AN INFECTION. THE PATIENT WAS PROVIDED WITH IV ANTIBIOTICS AND THE DEVICE WAS EXPLANTED. THERE WERE NO REPORTS OF FURTHER COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 7336543 ↗
• 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 AT THE LEAD INCISION SITE. THE WOUND WAS PACKED WITH SILVER AND THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. THERE HAVE BEEN NO FURTHER REPORTS OF COMPLICATIONS..

  Patient problems: Unspecified Infection

  MAUDE report 7217597 ↗