MEDTRONIC PUERTO RICO OPERATIONS CO.

Manufacturer adverse-event records for MEDTRONIC PUERTO RICO OPERATIONS CO. 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 · 2005–2026 · heavy-book · typical Death-code · balanced

Volume signature

MEDTRONIC PUERTO RICO OPERATIONS CO. sits in the heavy MAUDE book

MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 1,918,080 FDA MAUDE reports (#2 of 443, heavy-book tercile). Death-coded event_type share is 0.30% (typical); Injury share 19.9% (balanced).

What the volume reading shows for MEDTRONIC PUERTO RICO OPERATIONS CO.

The standout signal for MEDTRONIC PUERTO RICO OPERATIONS CO. is filing volume: 1,918,080 adverse-event reports in FDA MAUDE (#2 of 443, heavy-book). Death-coded event_type share sits at 0.30% (typical).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair MEDTRONIC PUERTO RICO OPERATIONS CO. 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 1,530,591 (79.8% of event_type total). Peak single-year volume reaches 276,898 reports across 22 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

1,918,080
Total Reports
5,712
Event-type Death
381,566
Injury Reports
20
Device Types

Event Types

Malfunction 1,530,591 (79.8%)
Injury 381,566 (19.9%)
Death 5,712 (0.3%)
193 (0.0%)
Other 18 (0.0%)

Patient Outcomes

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

1,544,119 (78.6%)
Other 196,024 (10.0%)
Required Intervention 86,690 (4.4%)
Hospitalization 77,536 (3.9%)
R 26,921 (1.4%)
H 11,668 (0.6%)
O 6,719 (0.3%)
Life Threatening 5,584 (0.3%)
Death 5,265 (0.3%)
L 2,490 (0.1%)
D 399 (0.0%)
S 157 (0.0%)
Disability 151 (0.0%)
Congenital Anomaly 71 (0.0%)
C 6 (0.0%)

Yearly Trend

05
2005: 2
06
2006: 1
07
2007: 606
08
2008: 3,197
09
2009: 3,855
10
2010: 2
11
2011: 1,119
12
2012: 6,453
13
2013: 11,659
14
2014: 47,630
15
2015: 110,064
16
2016: 96,204
17
2017: 128,842
18
2018: 147,214
19
2019: 184,081
20
2020: 185,549
21
2021: 150,266
22
2022: 276,898
23
2023: 183,695
24
2024: 173,162
25
2025: 176,654
26
2026: 30,927