MEDTRONIC EUROPE SARL

Manufacturer adverse-event records for MEDTRONIC EUROPE SARL 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 · 2004–2026 · heavy-book · elevated Death-code · balanced

Volume signature

MEDTRONIC EUROPE SARL sits in the heavy MAUDE book

MEDTRONIC EUROPE SARL accounts for 43,301 FDA MAUDE reports (#83 of 443, heavy-book tercile). Death-coded event_type share is 1.29% (elevated); Injury share 37.4% (balanced).

What the volume reading shows for MEDTRONIC EUROPE SARL

The standout signal for MEDTRONIC EUROPE SARL is filing volume: 43,301 adverse-event reports in FDA MAUDE (#83 of 443, heavy-book). Death-coded event_type share sits at 1.29% (elevated).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair MEDTRONIC EUROPE SARL 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 26,509 (61.2% of event_type total). Peak single-year volume reaches 5,313 reports across 23 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

43,301
Total Reports
557
Event-type Death
16,213
Injury Reports
20
Device Types

Event Types

Malfunction 26,509 (61.2%)
Injury 16,213 (37.4%)
Death 557 (1.3%)
Other 21 (0.0%)
1 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

22,249 (38.4%)
R 9,359 (16.1%)
Hospitalization 8,829 (15.2%)
Required Intervention 7,203 (12.4%)
H 4,047 (7.0%)
Life Threatening 3,898 (6.7%)
L 1,252 (2.2%)
Death 545 (0.9%)
Other 461 (0.8%)
O 73 (0.1%)
D 37 (0.1%)
S 7 (0.0%)
Disability 3 (0.0%)
Congenital Anomaly 2 (0.0%)

Yearly Trend

04
2004: 8
05
2005: 11
06
2006: 34
07
2007: 53
08
2008: 39
09
2009: 147
10
2010: 173
11
2011: 136
12
2012: 12
13
2013: 13
14
2014: 15
15
2015: 33
16
2016: 211
17
2017: 4,097
18
2018: 4,570
19
2019: 4,411
20
2020: 4,358
21
2021: 4,794
22
2022: 4,096
23
2023: 4,798
24
2024: 5,159
25
2025: 5,313
26
2026: 820