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2026 data FDA MAUDE openFDA FDA Class III

Programmer, Pacemaker

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 Class III (highest risk, premarket approval required), regulated under 21 CFR §870.3700 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Programmer, Pacemaker MID-BOOK · MAUDE

#126 of 1000 · 24,159 reports · 1992–2026

  • BOOK 24,159 reports
  • RANK #126 of 1000
  • DEATH 14 death-typed
  • INJ 781 injury-typed
  • MALF 23,352 malfunction
  • SPAN 1992–2026
  • PEAK 2015: 3,244
  • PHOTO Duodenoscope And Acce…

Nearest event-volume peer: Duodenoscope And Accessories, Flexible/Rigid (58 report gap)

Programmer, Pacemaker sits #126 of 1000 among tracked device types with 24,159 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 →

Malfunction reports run above the device-type norm

Programmer, Pacemaker carries 96.7% MALFUNCTION-coded reports, 31.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 3.2% corpus 30.3% · below corpus mean (-27.1 pp)
  • MALF 96.7% corpus 64.8% · above corpus mean (+31.8 pp)

Lead product-problem code Device Difficult to Program or Calibrate is 13% of coded problems · Lead manufacturer MEDTRONIC, INC. accounts for 87% of manufacturer-tagged reports · Top event location I is 47% of location-tagged rows .

Programmer, Pacemaker in the event-volume neighbourhood

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

reports

What this shows Programmer, Pacemaker carries 24,159 MAUDE reports, ranked #126 of 1000.

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

Event Types

Malfunction 23,352 (96.7%)
Injury 781 (3.2%)
Death 14 (0.1%)
Other 8 (0.0%)
4 (0.0%)

Patient Outcomes

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

21,059 (84.7%)
Other 2,162 (8.7%)
R 422 (1.7%)
Hospitalization 389 (1.6%)
Required Intervention 354 (1.4%)
L 320 (1.3%)
Life Threatening 93 (0.4%)
H 18 (0.1%)
O 17 (0.1%)
Death 13 (0.1%)
Invalid Data 2 (0.0%)

Top Product Problems

Device Difficult to Program or Calibrate 3,382
No Display/Image 3,118
Communication or Transmission Problem 2,205
Electrical /Electronic Property Problem 2,038
Computer Operating System Problem 2,012
Computer Software Problem 1,743
Output Problem 1,607
Display or Visual Feedback Problem 1,579
Failure to Calibrate 1,111
Mechanical Problem 970
Failure to Power Up 867
Device Operates Differently Than Expected 822
Failure to Interrogate 757
Unexpected Shutdown 752
Power Problem 706
Connection Problem 692
Overheating of Device 636
Inadequate User Interface 603
Device Displays Incorrect Message 562
Problem with Software Installation 478

Yearly Trend

92
1992: 1
94
1994: 2
95
1995: 1
96
1996: 5
97
1997: 31
98
1998: 18
99
1999: 3
00
2000: 8
01
2001: 5
02
2002: 1
03
2003: 7
04
2004: 8
05
2005: 4
06
2006: 15
07
2007: 20
08
2008: 11
09
2009: 14
10
2010: 26
11
2011: 731
12
2012: 1,488
13
2013: 1,377
14
2014: 2,541
15
2015: 3,244
16
2016: 1,886
17
2017: 1,407
18
2018: 1,326
19
2019: 1,174
20
2020: 1,689
21
2021: 1,700
22
2022: 1,359
23
2023: 1,069
24
2024: 1,545
25
2025: 827
26
2026: 616

Reports fell to 827 in 2025, down from an average of 1,307 in the two years before.

Related Entities for Programmer, Pacemaker

Top Manufacturers

MEDTRONIC, INC. 20,309
GUIDANT CRM CLONMEL IRELAND 587
MICROPORT CRM S.R.L. 563
SORIN GROUP ITALIA S.R.L. - CRM FACILITY 554
PLEXUS MANUFACTURING SDN. BHD 523
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 280
MEDTRONIC INC. 246
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 183
ST. JUDE MEDICAL, INC. 73

Event Locations

I 11,310 (46.8%)
10,059 (41.6%)
HOSPITAL 2,307 (9.5%)
NO INFORMATION 334 (1.4%)
UNKNOWN 39 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 30 (0.1%)
OTHER 29 (0.1%)
OUTPATIENT TREATMENT FACILITY 24 (0.1%)
INVALID DATA 16 (0.1%)
HOME 6 (0.0%)
AMBULATORY HEALTH CARE FACILITY 3 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
NURSING HOME 1 (0.0%)

Compare MEDTRONIC, INC. vs GUIDANT CRM CLONMEL IRELAND →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Programmer, Pacemaker: 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 (24,159 here).

Duodenoscope And Accessories, Flexible/Rigid 24,101 Instrument, Biopsy 23,840 Thoracolumbosacral Pedicle Screw System 24,647 Counter, Differential Cell 23,439

Similar death-typed counts

Nearest other device types by death-typed report count (14 here), distinct from the volume row.

Bed 14 Glucose Oxidase, Glucose 14 Implant, Dermal, For Aesthetic Use 14 Spinal Vertebral Body Replacement Device 14

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Programmer, Pacemaker 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 Programmer, Pacemaker; 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.