MEDTRONIC SINGAPORE OPERATIONS

FDA MAUDE device safety record · 2011–2026

What the Data Shows About MEDTRONIC SINGAPORE OPERATIONS

MEDTRONIC SINGAPORE OPERATIONS is associated with 54,416 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2011 through 2026. Of the total, 821 are coded as death reports and 20,000 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 13 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for MEDTRONIC SINGAPORE OPERATIONS 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 33,595 reports (61.7% 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 16 years of MAUDE data, with the peak single-year volume reaching 9,820 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.

54,416
Total Reports
821
Death Reports
20,000
Injury Reports
13
Device Types

Event Types

Malfunction 33,595 (61.7%)
Injury 20,000 (36.8%)
Death 821 (1.5%)

Patient Outcomes

32,651 (45.4%)
R 10,854 (15.1%)
Hospitalization 10,548 (14.7%)
Required Intervention 8,578 (11.9%)
H 5,021 (7.0%)
L 1,678 (2.3%)
Life Threatening 1,201 (1.7%)
Death 796 (1.1%)
Other 531 (0.7%)
O 86 (0.1%)
D 34 (0.0%)
Congenital Anomaly 5 (0.0%)
C 1 (0.0%)
S 1 (0.0%)

Yearly Trend

11
2011: 5
12
2012: 56
13
2013: 271
14
2014: 537
15
2015: 691
16
2016: 1,104
17
2017: 1,664
18
2018: 2,633
19
2019: 3,534
20
2020: 3,435
21
2021: 4,893
22
2022: 6,236
23
2023: 8,509
24
2024: 9,574
25
2025: 9,820
26
2026: 1,454

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.