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VOLTA 2CR 60/16Recalls & reported problems

BIOTRONIK SE & Co. KG · Class 3 · Implant

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 04035479143398), received between Jun 29, 2018 and Jun 29, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Ambient Noise 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Ambient Noise Problem1
  • Inappropriate/Inadequate Shock/Stimulation1

Patient problems

  • Shock from Patient Lead(s)1

Recent adverse event reports

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

  • InjuryJun 29, 2018Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem

    IT WAS REPORTED THIS RV LEAD WAS EXPLANTED AND REPLACED DUE TO INAPPROPRIATE SHOCKS AND NOISE.

    Patient problems: Shock from Patient Lead(s)

    MAUDE report 7651176 ↗

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