2026 data FDA MAUDE openFDA

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

#37 of 1000 · 114,088 reports · 1992–2026

  • BOOK 114,088 reports
  • RANK #37 of 1000
  • DEATH 1,628 death-typed
  • INJ 73,723 injury-typed
  • MALF 36,430 malfunction
  • SPAN 1992–2026
  • PEAK 2016: 8,462
  • PHOTO Electrosurgical

Nearest event-volume peer: Electrosurgical, Cutting & Coagulation & Accessories (429 report gap)

Pump, Infusion, Implanted, Programmable sits #37 of 1000 among tracked device types with 114,088 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
  • INJ 64.6% corpus 30.4% · above corpus mean (+34.2 pp)
  • MALF 31.9% corpus 64.5% · below corpus mean (-32.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 21% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 41% of manufacturer-tagged reports · Top event location I 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 114,088 MAUDE reports, ranked #37 of 1000.

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

Event Types

Injury 73,723 (64.6%)
Malfunction 36,430 (31.9%)
Other 2,205 (1.9%)
Death 1,628 (1.4%)
102 (0.1%)

Patient Outcomes

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

Required Intervention 51,894 (40.0%)
33,142 (25.5%)
Hospitalization 18,267 (14.1%)
R 11,261 (8.7%)
Other 7,918 (6.1%)
L 2,230 (1.7%)
Death 1,628 (1.3%)
O 1,349 (1.0%)
Life Threatening 999 (0.8%)
H 794 (0.6%)
S 272 (0.2%)
Disability 90 (0.1%)
Congenital Anomaly 24 (0.0%)
D 23 (0.0%)
C 3 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 15,379
Insufficient Flow or Under Infusion 5,961
Pumping Stopped 5,601
Infusion or Flow Problem 5,213
Insufficient Information 5,180
Migration or Expulsion of Device 4,781
Material Integrity Problem 4,547
Device Operates Differently Than Expected 3,856
Communication or Transmission Problem 3,181
Obstruction of Flow 2,981
Device Displays Incorrect Message 2,387
Electromagnetic Interference 2,074
Improper or Incorrect Procedure or Method 1,991
Filling Problem 1,795
Volume Accuracy Problem 1,534
Fluid/Blood Leak 1,485
Aspiration Issue 1,418
Excess Flow or Over-Infusion 1,347
Failure To Service 1,232
Intermittent Infusion 1,109

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: 1,111
04
2004: 1,151
05
2005: 1,265
06
2006: 1,807
07
2007: 2,676
08
2008: 3,398
09
2009: 3,223
10
2010: 4,066
11
2011: 3,913
12
2012: 5,557
13
2013: 8,055
14
2014: 7,458
15
2015: 8,452
16
2016: 8,462
17
2017: 7,751
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: 1,317

Related Entities for Pump, Infusion, Implanted, Programmable

Event Locations

I 45,100 (39.5%)
44,092 (38.6%)
OTHER 15,637 (13.7%)
UNKNOWN 8,315 (7.3%)
HOSPITAL 466 (0.4%)
NO INFORMATION 238 (0.2%)
HOME 100 (0.1%)
INVALID DATA 91 (0.1%)
OUTPATIENT TREATMENT FACILITY 31 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Pump, Infusion, Implanted, Programmable, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (114,088 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1,628 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.