MEDTRONIC PUERTO RICO, INC.

Manufacturer adverse-event records for MEDTRONIC PUERTO RICO, 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 · 1996–2012 · heavy-book · elevated Death-code · injury-heavy

Death-code intensity

MEDTRONIC PUERTO RICO, INC. carries an elevated Death-code share

Death-coded event_type rows are 8,203 of 69,774 (11.76% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for MEDTRONIC PUERTO RICO, INC.

The standout signal for MEDTRONIC PUERTO RICO, INC. is Death-code intensity: 11.76% of 69,774 reports (elevated tercile), while absolute volume is heavy-book.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair MEDTRONIC PUERTO RICO, INC. 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 Injury at 40,561 (58.1% of event_type total). Peak single-year volume reaches 19,072 reports across 17 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

69,774
Total Reports
8,203
Event-type Death
40,561
Injury Reports
20
Device Types

Event Types

Injury 40,561 (58.1%)
Malfunction 20,797 (29.8%)
Death 8,203 (11.8%)
211 (0.3%)
No answer provided 1 (0.0%)
Other 1 (0.0%)

Patient Outcomes

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

Other 21,853 (22.5%)
R 21,814 (22.4%)
Hospitalization 19,843 (20.4%)
Required Intervention 19,421 (20.0%)
Death 7,885 (8.1%)
L 2,978 (3.1%)
O 2,058 (2.1%)
Life Threatening 609 (0.6%)
H 589 (0.6%)
164 (0.2%)
D 57 (0.1%)
S 13 (0.0%)
Disability 3 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

96
1996: 5
97
1997: 825
98
1998: 620
99
1999: 195
00
2000: 588
01
2001: 645
02
2002: 607
03
2003: 599
04
2004: 492
05
2005: 910
06
2006: 1,654
07
2007: 3,171
08
2008: 4,102
09
2009: 4,532
10
2010: 14,680
11
2011: 19,072
12
2012: 17,077