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 1,986,513 FDA MAUDE reports (#2 of 434, heavy-book tercile). Death-coded event_type share is 0.29% (typical); Injury share 19.8% (balanced).

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

The standout signal for MEDTRONIC PUERTO RICO OPERATIONS CO. is filing volume: 1,986,513 adverse-event reports in FDA MAUDE (#2 of 434, heavy-book). Death-coded event_type share sits at 0.29% (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 1,587,117 (79.9% of event_type total). Peak single-year volume reaches 276,899 reports across 22 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

1,986,513
Total Reports
5,763
Event-type Death
393,422
Injury Reports
20
Device Types

Event Types

Malfunction 1,587,117 (79.9%)
Injury 393,422 (19.8%)
Death 5,763 (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.

1,599,075 (78.7%)
Other 202,505 (10.0%)
Required Intervention 90,000 (4.4%)
Hospitalization 78,290 (3.9%)
R 27,607 (1.4%)
H 12,326 (0.6%)
O 6,775 (0.3%)
Life Threatening 5,699 (0.3%)
Death 5,302 (0.3%)
L 2,528 (0.1%)
D 411 (0.0%)
Disability 158 (0.0%)
S 157 (0.0%)
Congenital Anomaly 72 (0.0%)
C 9 (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: 150,267
22
2022: 276,899
23
2023: 183,695
24
2024: 173,162
25
2025: 176,669
26
2026: 99,343