MEDTRONIC NAVIGATION, INC. (LOUISVILLE)

Manufacturer adverse-event records for MEDTRONIC NAVIGATION, INC. 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 · 2015–2020 · mid-book · typical Death-code · injury-light

Injury-mix signature

MEDTRONIC NAVIGATION, INC. is lighter on Injury codes

Injury-coded event_type share is 8.4% (injury-light tercile) beside 0.37% Death-coded (typical). Volume band: mid.

What the Injury-mix reading shows for MEDTRONIC NAVIGATION, INC. (LOUISVILLE)

The standout signal for MEDTRONIC NAVIGATION, INC. (LOUISVILLE) is Injury-mix: 8.4% Injury-coded (injury-light) beside 0.37% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for MEDTRONIC NAVIGATION, INC.. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 11 device types, led in this extract by Malfunction at 7,597 (91.2% of event_type total). Peak single-year volume reaches 2,860 reports across 6 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

8,331
Total Reports
31
Event-type Death
703
Injury Reports
11
Device Types

Event Types

Malfunction 7,597 (91.2%)
Injury 703 (8.4%)
Death 31 (0.4%)

Patient Outcomes

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

7,584 (88.9%)
Required Intervention 480 (5.6%)
Other 125 (1.5%)
R 94 (1.1%)
S 62 (0.7%)
Hospitalization 41 (0.5%)
Death 37 (0.4%)
Disability 33 (0.4%)
Life Threatening 31 (0.4%)
O 21 (0.2%)
L 15 (0.2%)
H 5 (0.1%)

Yearly Trend

15
2015: 939
16
2016: 1,757
17
2017: 2,860
18
2018: 2,762
19
2019: 12
20
2020: 1