MEDTRONIC MED REL MEDTRONIC PUERTO RICO

FDA MAUDE device safety record · 2005–2025

What the Data Shows About MEDTRONIC MED REL MEDTRONIC PUERTO RICO

MEDTRONIC MED REL MEDTRONIC PUERTO RICO is associated with 88,055 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2005 through 2025. Of the total, 1,205 are coded as death reports and 48,580 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 MED REL MEDTRONIC PUERTO RICO should be reviewed at the device-family level rather than company-wide. Across those devices, 4 distinct event types appear in the record, led by Injury at 48,580 reports (55.2% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 21 years of MAUDE data, with the peak single-year volume reaching 18,181 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.

88,055
Total Reports
1,205
Death Reports
48,580
Injury Reports
20
Device Types

Event Types

Injury 48,580 (55.2%)
Malfunction 38,269 (43.5%)
Death 1,205 (1.4%)
1 (0.0%)

Patient Outcomes

37,782 (34.9%)
Required Intervention 27,124 (25.1%)
Hospitalization 18,097 (16.7%)
R 17,836 (16.5%)
Other 1,926 (1.8%)
Life Threatening 1,814 (1.7%)
L 1,289 (1.2%)
Death 1,209 (1.1%)
H 655 (0.6%)
O 235 (0.2%)
S 85 (0.1%)
Disability 71 (0.1%)
Congenital Anomaly 13 (0.0%)
D 5 (0.0%)

Yearly Trend

05
2005: 2
06
2006: 2
07
2007: 4
08
2008: 23
09
2009: 25
10
2010: 38
11
2011: 90
12
2012: 6,383
13
2013: 18,181
14
2014: 16,638
15
2015: 12,070
16
2016: 9,275
17
2017: 7,024
18
2018: 5,638
19
2019: 3,727
20
2020: 2,607
21
2021: 1,800
22
2022: 1,518
23
2023: 1,607
24
2024: 1,080
25
2025: 323

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.