BIOTRONIK AG, BUELACH, SWITZERLAND
Manufacturer adverse-event records for BIOTRONIK AG, BUELACH, SWITZERLAND 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 · 2019–2025 · thin-book · elevated Death-code · injury-light
Volume signature
BIOTRONIK AG, BUELACH, SWITZERLAND is a thinner MAUDE footprint
BIOTRONIK AG, BUELACH, SWITZERLAND accounts for 3,561 FDA MAUDE reports (#440 of 443, thin-book tercile). Death-coded event_type share is 2.89% (elevated); Injury share 5.4% (injury-light).
What the volume reading shows for BIOTRONIK AG, BUELACH, SWITZERLAND
The standout signal for BIOTRONIK AG, BUELACH, SWITZERLAND is filing volume: 3,561 adverse-event reports in FDA MAUDE (#440 of 443, thin-book). Death-coded event_type share sits at 2.89% (elevated).
As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.
Reports span 8 device types, led in this extract by Malfunction at 3,267 (91.7% of event_type total). Peak single-year volume reaches 628 reports across 7 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 (8)
Yearly Trend
Read our methodology - how this data is sourced, computed, and verified.