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NURO™ 3533Recalls & reported problems

Medtronic, Inc. · ENS 3533 NURO EXTERNAL NEUROSTIMULATOR · Class 2

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 00643169654624), received between Apr 28, 2017 and Apr 28, 2017 — 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

  • Complaint, Ill-Defined1

Recent adverse event reports

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

  • InjuryApr 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A MANUFACTURING REPRESENTATIVE (REP) REPORTED ON BEHALF OF A HEALTHCARE PROFESSIONAL (HCP) THAT A PATIENT EXPERIENCED RHABDOMYOLYSIS OF AN UNKNOWN ETIOLOGY THE DAY FOLLOWING TREATMENT WITH PTNM THERAPY. THE PATIENT WAS HOSPITALIZED FOR 4 DAYS. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Patient problems: Complaint, Ill-Defined

    MAUDE report 6530005 ↗

Other STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.