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Nevro® LEAD2008-35B (UDI 00813426020060)Recalls & reported problems

Nevro Corp. · Blue Lead Extension Kit, 35cm · Class 3

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813426020060), received between Sep 5, 2019 and Sep 5, 2019 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED TO NEVRO THAT THE PATIENT HAD AN INFECTION AT THE LEAD EXTENSION SITE. THE SYSTEM WAS REMOVED AND THE PATIENT WAS GIVEN ANTIBIOTICS. NEVRO ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE INFECTION BUT WAS UNSUCCESSFUL. THE PATIENT CONTINUES TO BE UNDER MEDICAL SUPERVISION IN THE HOSPITAL.

    Patient problems: Unspecified Infection

    MAUDE report 8966339 ↗

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Sources and updates

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