MEDTRONIC PUERTO RICO VILLALBA

Manufacturer adverse-event records for MEDTRONIC PUERTO RICO VILLALBA 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 · 2011–2026 · heavy-book · elevated Death-code · balanced

Volume signature

MEDTRONIC PUERTO RICO VILLALBA sits in the heavy MAUDE book

MEDTRONIC PUERTO RICO VILLALBA accounts for 42,157 FDA MAUDE reports (#92 of 434, heavy-book tercile). Death-coded event_type share is 0.97% (elevated); Injury share 45.3% (balanced).

What the volume reading shows for MEDTRONIC PUERTO RICO VILLALBA

The standout signal for MEDTRONIC PUERTO RICO VILLALBA is filing volume: 42,157 adverse-event reports in FDA MAUDE (#92 of 434, heavy-book). Death-coded event_type share sits at 0.97% (elevated).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair MEDTRONIC PUERTO RICO VILLALBA 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 22,633 (53.7% of event_type total). Peak single-year volume reaches 21,850 reports across 16 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

42,157
Total Reports
408
Event-type Death
19,116
Injury Reports
20
Device Types

Event Types

Malfunction 22,633 (53.7%)
Injury 19,116 (45.3%)
Death 408 (1.0%)

Patient Outcomes

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

21,680 (38.9%)
Required Intervention 9,840 (17.7%)
H 7,356 (13.2%)
R 7,242 (13.0%)
Hospitalization 6,862 (12.3%)
Life Threatening 1,154 (2.1%)
L 963 (1.7%)
Death 356 (0.6%)
Other 172 (0.3%)
D 45 (0.1%)
O 17 (0.0%)
Congenital Anomaly 3 (0.0%)
C 2 (0.0%)
S 1 (0.0%)
Disability 1 (0.0%)

Yearly Trend

11
2011: 1
12
2012: 1
13
2013: 1
14
2014: 7
15
2015: 6
16
2016: 8
17
2017: 17
18
2018: 33
19
2019: 47
20
2020: 59
21
2021: 80
22
2022: 130
23
2023: 231
24
2024: 403
25
2025: 19,283
26
2026: 21,850