MEDTRONIC, INC.

Manufacturer adverse-event records for MEDTRONIC, INC. 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 · 1992–2026 · heavy-book · elevated Death-code · balanced

Volume signature

MEDTRONIC, INC. sits in the heavy MAUDE book

MEDTRONIC, INC. accounts for 77,710 FDA MAUDE reports (#41 of 443, heavy-book tercile). Death-coded event_type share is 2.21% (elevated); Injury share 24.0% (balanced).

What the volume reading shows for MEDTRONIC, INC.

The standout signal for MEDTRONIC, INC. is filing volume: 77,710 adverse-event reports in FDA MAUDE (#41 of 443, heavy-book). Death-coded event_type share sits at 2.21% (elevated).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair MEDTRONIC, INC. 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 56,701 (73.0% of event_type total). Peak single-year volume reaches 14,998 reports across 35 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

77,710
Total Reports
1,714
Event-type Death
18,614
Injury Reports
20
Device Types

Event Types

Malfunction 56,701 (73.0%)
Injury 18,614 (24.0%)
Death 1,714 (2.2%)
Other 499 (0.6%)
180 (0.2%)
No answer provided 2 (0.0%)

Patient Outcomes

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

50,472 (55.4%)
Hospitalization 9,123 (10.0%)
R 9,100 (10.0%)
Other 7,533 (8.3%)
Required Intervention 7,152 (7.9%)
H 2,205 (2.4%)
L 1,810 (2.0%)
Death 1,697 (1.9%)
Life Threatening 1,384 (1.5%)
O 375 (0.4%)
S 123 (0.1%)
Disability 40 (0.0%)
D 38 (0.0%)
Congenital Anomaly 9 (0.0%)
Invalid Data 2 (0.0%)

Yearly Trend

92
1992: 8
93
1993: 25
94
1994: 178
95
1995: 123
96
1996: 231
97
1997: 501
98
1998: 259
99
1999: 236
00
2000: 344
01
2001: 459
02
2002: 513
03
2003: 106
04
2004: 183
05
2005: 249
06
2006: 202
07
2007: 163
08
2008: 379
09
2009: 451
10
2010: 1,129
11
2011: 3,702
12
2012: 4,323
13
2013: 2,192
14
2014: 3,623
15
2015: 4,611
16
2016: 2,872
17
2017: 2,201
18
2018: 2,278
19
2019: 2,337
20
2020: 3,572
21
2021: 5,042
22
2022: 4,108
23
2023: 4,351
24
2024: 6,327
25
2025: 14,998
26
2026: 5,434