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Prospera Trial AccRecalls & reported problems

BIOTRONIK SE & Co. KG · Class 3

All models of Prospera (2)

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 04035479170158), received between Aug 7, 2023 and Aug 7, 2023 — 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

  • Skin Inflammation/ Irritation1

Recent adverse event reports

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

  • InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    SYSTEM WAS REMOVED DUE TO SKIN IRRITATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Patient problems: Skin Inflammation/ Irritation

    MAUDE report 17469838 ↗

Other Stimulator, spinal-cord, totally implanted for pain relief devices

All Stimulator, spinal-cord, totally implanted for pain relief devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page