2026 data FDA MAUDE openFDA FDA Class III

Pump, Infusion, Implanted, Programmable

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

openFDA event book Pump, Infusion, Implanted, Programmable HEAVY-BOOK · MAUDE

#38 of 1000 · 116,799 reports · 1992–2026

  • BOOK 116,799 reports
  • RANK #38 of 1000
  • DEATH 1,634 death-typed
  • INJ 74,805 injury-typed
  • MALF 38,040 malfunction
  • SPAN 1992–2026
  • PEAK 2016: 8,462
  • PHOTO Sensor

Nearest event-volume peer: Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated (349 report gap)

Pump, Infusion, Implanted, Programmable sits #38 of 1000 among tracked device types with 116,799 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports run above the device-type norm

Pump, Infusion, Implanted, Programmable carries 64.0% INJURY-coded reports, 33.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
  • INJ 64.0% corpus 30.3% · above corpus mean (+33.8 pp)
  • MALF 32.6% corpus 64.8% · below corpus mean (-32.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 20% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 43% of manufacturer-tagged reports · Top event location is 40% of location-tagged rows .

Pump, Infusion, Implanted, Programmable in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Pump, Infusion, Implanted, Programmable carries 116,799 MAUDE reports, ranked #38 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 74,805 (64.0%)
Malfunction 38,040 (32.6%)
Other 2,218 (1.9%)
Death 1,634 (1.4%)
102 (0.1%)

Patient Outcomes

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

Required Intervention 52,502 (39.8%)
34,378 (26.0%)
Hospitalization 18,348 (13.9%)
R 11,298 (8.6%)
Other 7,981 (6.0%)
L 2,250 (1.7%)
Death 1,628 (1.2%)
O 1,360 (1.0%)
Life Threatening 1,020 (0.8%)
H 833 (0.6%)
S 275 (0.2%)
Disability 90 (0.1%)
D 26 (0.0%)
Congenital Anomaly 24 (0.0%)
C 4 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 25,203
Device Operates Differently Than Expected 9,465
Pumping Stopped 8,659
Insufficient Device Problem Information 8,183
Insufficient Flow or Under Infusion 7,836
Migration or Expulsion of Device 6,708
Material Integrity Problem 6,593
Explanted 6,571
Infusion or Flow Problem 5,613
Volume Accuracy Problem 5,410
Device Displays Incorrect Message 5,310
Improper or Incorrect Procedure or Method 4,639
Communication or Transmission Problem 4,385
Replace 4,097
Aspiration Issue 3,248
Obstruction of Flow 3,194
Electromagnetic Interference 3,097
Device remains implanted 2,950
Filling Problem 2,931
Unstable 2,554

Yearly Trend

92
1992: 2
93
1993: 2
94
1994: 14
95
1995: 14
96
1996: 48
97
1997: 315
98
1998: 316
99
1999: 265
00
2000: 364
01
2001: 945
02
2002: 938
03
2003: 1,112
04
2004: 1,153
05
2005: 1,273
06
2006: 1,822
07
2007: 2,693
08
2008: 3,398
09
2009: 3,224
10
2010: 4,066
11
2011: 3,915
12
2012: 5,557
13
2013: 8,054
14
2014: 7,458
15
2015: 8,452
16
2016: 8,462
17
2017: 7,752
18
2018: 6,936
19
2019: 5,652
20
2020: 5,115
21
2021: 4,713
22
2022: 4,310
23
2023: 4,041
24
2024: 4,619
25
2025: 5,817
26
2026: 3,982

Reports in 2025 (5,817) held close to the prior two-year average of 4,330.

Related Entities for Pump, Infusion, Implanted, Programmable

Event Locations

46,802 (40.1%)
I 45,078 (38.6%)
OTHER 15,650 (13.4%)
UNKNOWN 8,307 (7.1%)
HOSPITAL 468 (0.4%)
NO INFORMATION 238 (0.2%)
HOME 100 (0.1%)
INVALID DATA 91 (0.1%)
OUTPATIENT TREATMENT FACILITY 31 (0.0%)
0 16 (0.0%)
AMBULATORY SURGICAL FACILITY 8 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 7 (0.0%)
NURSING HOME 3 (0.0%)

Compare MEDTRONIC PUERTO RICO OPERATIONS CO. vs MDT PUERTO RICO OPERATIONS CO →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pump, Infusion, Implanted, Programmable: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (116,799 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1,634 here), distinct from the volume row.

Disclaimer: MAUDE figures for Pump, Infusion, Implanted, Programmable are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Pump, Infusion, Implanted, Programmable; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.