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 45,471 FDA MAUDE reports (#85 of 434, heavy-book tercile). Death-coded event_type share is 1.32% (elevated); Injury share 38.6% (balanced).

What the volume reading shows for MEDTRONIC EUROPE SARL

The standout signal for MEDTRONIC EUROPE SARL is filing volume: 45,471 adverse-event reports in FDA MAUDE (#85 of 434, heavy-book). Death-coded event_type share sits at 1.32% (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 27,311 (60.1% of event_type total). Peak single-year volume reaches 5,312 reports across 23 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

45,471
Total Reports
600
Event-type Death
17,538
Injury Reports
20
Device Types

Event Types

Malfunction 27,311 (60.1%)
Injury 17,538 (38.6%)
Death 600 (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.

22,842 (37.7%)
R 9,726 (16.1%)
Hospitalization 9,167 (15.1%)
Required Intervention 7,668 (12.7%)
H 4,405 (7.3%)
Life Threatening 4,232 (7.0%)
L 1,339 (2.2%)
Death 584 (1.0%)
Other 481 (0.8%)
O 76 (0.1%)
D 39 (0.1%)
S 7 (0.0%)
Congenital Anomaly 3 (0.0%)
Disability 3 (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: 5,312
26
2026: 2,991