BIOTRONIK SE & CO. KG
Manufacturer adverse-event records for BIOTRONIK SE & CO. KG come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.
FDA MAUDE device safety record · 2009–2026 · heavy-book · elevated Death-code · balanced
Volume signature
BIOTRONIK SE & CO. KG sits in the heavy MAUDE book
BIOTRONIK SE & CO. KG accounts for 74,563 FDA MAUDE reports (#48 of 434, heavy-book tercile). Death-coded event_type share is 0.94% (elevated); Injury share 41.3% (balanced).
What the volume reading shows for BIOTRONIK SE & CO. KG
The standout signal for BIOTRONIK SE & CO. KG is filing volume: 74,563 adverse-event reports in FDA MAUDE (#48 of 434, heavy-book). Death-coded event_type share sits at 0.94% (elevated).
As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair BIOTRONIK SE & CO. KG with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.
Reports span 20 device types, led in this extract by Malfunction at 42,795 (57.4% of event_type total). Peak single-year volume reaches 6,379 reports across 18 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Devices (20)
Yearly Trend
Read our methodology - how this data is sourced, computed, and verified.