MEDTRONIC PUERTO RICO VILLALBA

FDA MAUDE device safety record · 2008–2026

What the Data Shows About MEDTRONIC PUERTO RICO VILLALBA

MEDTRONIC PUERTO RICO VILLALBA is associated with 26,161 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2008 through 2026. Of the total, 263 are coded as death reports and 12,137 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for MEDTRONIC PUERTO RICO VILLALBA should be reviewed at the device-family level rather than company-wide. Across those devices, 3 distinct event types appear in the record, led by Malfunction at 13,761 reports (52.6% of total). Patient-outcome categorizations are reported across 15 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 16 years of MAUDE data, with the peak single-year volume reaching 19,145 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

26,161
Total Reports
263
Death Reports
12,137
Injury Reports
20
Device Types

Event Types

Malfunction 13,761 (52.6%)
Injury 12,137 (46.4%)
Death 263 (1.0%)

Patient Outcomes

13,609 (37.3%)
Required Intervention 6,662 (18.2%)
H 4,985 (13.6%)
R 4,867 (13.3%)
Hospitalization 4,602 (12.6%)
Life Threatening 777 (2.1%)
L 627 (1.7%)
Death 225 (0.6%)
Other 108 (0.3%)
D 37 (0.1%)
O 21 (0.1%)
C 2 (0.0%)
S 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)

Yearly Trend

08
2008: 1
11
2011: 2
13
2013: 2
14
2014: 8
15
2015: 8
16
2016: 10
17
2017: 13
18
2018: 45
19
2019: 50
20
2020: 67
21
2021: 85
22
2022: 137
23
2023: 230
24
2024: 444
25
2025: 19,145
26
2026: 5,914

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.