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Senza ACCK4310Recalls & reported problems

Nevro Corp. · TSM Pouch Kit · Class 3

All models of Senza (13)

Data updated Oct 16, 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 00813426020671), received between Jun 13, 2022 and Jun 13, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Hypersensitivity/Allergic reaction1

Recent adverse event reports

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

  • InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN BURN FROM A REACTION TO THE ADHESIVE OF THE DEVICE POUCH. THE POUCH WAS REMOVED AND THE SKIN BURN WAS TREATED. THE PATIENT CONTINUED TO TRIAL AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 14681124 ↗

Other Stimulator, Spinal-Cord, Totally Implanted For Pain Relief devices

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Sources and updates

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