Nevro® LEAD2008-60B (UDI 00813426020084)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813426020084), received between Dec 20, 2019 and Jun 27, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN STAPH INFECTION AT THE LEAD INCISION SITE. THE PATIENT RECEIVED ORAL ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 19627671 ↗
• InjuryDec 20, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO NEVRO THAT DURING THE TRIAL, A PATIENT WAS IMPLANTED WITH A TRIAL LEAD EXTENSION FROM THE HOSPITAL¿S INVENTORY. FOLLOWING THE PROCEDURE, NEVRO FOUND THAT THE LEAD EXTENSION WAS PAST ITS EXPIRATION DATE AND IMMEDIATELY NOTIFIED THE HOSPITAL STAFF. THE IMPLANTING PHYSICIAN DECIDED TO LEAVE THE LEAD EXTENSION IN UNTIL THE PERMANENT IMPLANT AND CLOSELY MONITORED THE PATIENT. THE TRIAL ENDED SUCCESSFULLY AND WITHOUT COMPLICATIONS. THE PATIENT PLANNED TO MOVE FORWARD WITH A PERMANENT IMPLANT IN THE FUTURE. TWO DAYS AFTER THE END OF TRIAL, THE PATIENT PRESENTED WITH AN INFECTION. NEVRO ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE INFECTION BUT WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED, AND THE PATIENT RECOVERED WITHOUT SEQUALAE.

  Patient problems: Unspecified Infection

  MAUDE report 9507687 ↗