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e-vive NMES System; Small/Medium, Left (2.0 Dock) CY-1000-216Recalls & reported problems

Motive Health, Inc. · e-vive NMES System; Small/Medium, Left (2.0 Dock) · Class 1

Data updated Oct 18, 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 00854691008414), received between Mar 16, 2020 and Mar 16, 2020 — classified as 1 injury.

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 18, 2026.

Most reported problems

Device problems

  • Use of Device Problem1

Patient problems

  • Burning Sensation1
  • Muscle Stimulation1
  • Tissue Damage1

Recent adverse event reports

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

  • InjuryMar 16, 2020Use of Device Problem; Use of Device Problem

    THE PATIENT/SUBJECT IS CURRENTLY ENROLLED IN (B)(6) CLINICAL STUDY ((B)(6)). ON (B)(6) 2020, THE SUBJECT NOTIFIED THE SITE THAT SHE HAD MARKS CONSISTENT WITH A BURN IN THE LOCATION OF THE DEVICE ELECTRODES. TREATMENT WAS TEMPORARILY STOPPED FOR 2 DAYS THEN RESUMED ON (B)(6) 2020 UNDER THE CARE OF THE PRINCIPAL INVESTIGATOR.

    Patient problems: Burning Sensation; Muscle Stimulation; Tissue Damage

    MAUDE report 9835882 ↗

Sources and updates

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