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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Programmer, Pacemaker MID-BOOK · MAUDE

#123 of 1000 · 23,727 reports · 1992–2026

  • BOOK 23,727 reports
  • RANK #123 of 1000
  • DEATH 14 death-typed
  • INJ 775 injury-typed
  • MALF 22,926 malfunction
  • SPAN 1992–2026
  • PEAK 2015: 3,244
  • PHOTO Fastener

Nearest event-volume peer: Fastener, Fixation, Nondegradable, Soft Tissue (2 report gap)

Programmer, Pacemaker sits #123 of 1000 among tracked device types with 23,727 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 0.1% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 3.3% corpus 30.4% · below corpus mean (-27.2 pp)
  • MALF 96.6% corpus 64.5% · above corpus mean (+32.1 pp)

Lead product-problem code Device Difficult to Program or Calibrate is 16% of coded problems · Lead manufacturer MEDTRONIC, INC. accounts for 87% of manufacturer-tagged reports · Top event location I is 48% 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 23,727 MAUDE reports, ranked #123 of 1000.

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

Event Types

Malfunction 22,926 (96.6%)
Injury 775 (3.3%)
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.

20,697 (84.6%)
Other 2,160 (8.8%)
R 419 (1.7%)
Hospitalization 385 (1.6%)
Required Intervention 352 (1.4%)
L 319 (1.3%)
Life Threatening 92 (0.4%)
H 17 (0.1%)
O 16 (0.1%)
Death 13 (0.1%)
Invalid Data 2 (0.0%)

Top Product Problems

Device Difficult to Program or Calibrate 2,849
No Display/Image 2,547
Display or Visual Feedback Problem 1,426
Output Problem 1,393
Computer Operating System Problem 1,384
Failure to Calibrate 982
Computer Software Problem 929
Unexpected Shutdown 722
Electrical /Electronic Property Problem 616
Communication or Transmission Problem 606
Overheating of Device 505
Mechanical Problem 502
Failure to Power Up 486
Power Problem 482
Device Operates Differently Than Expected 458
Problem with Software Installation 382
Inadequate User Interface 364
Connection Problem 358
Use of Device Problem 282
Material Integrity Problem 281

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: 14
07
2007: 19
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: 186

Related Entities for Programmer, Pacemaker

Top Manufacturers

MEDTRONIC, INC. 19,958
GUIDANT CRM CLONMEL IRELAND 587
SORIN GROUP ITALIA S.R.L. - CRM FACILITY 554
PLEXUS MANUFACTURING SDN. BHD 523
MICROPORT CRM S.R.L. 509
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 280
MEDTRONIC INC. 246
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 183

Event Locations

I 11,311 (47.7%)
9,629 (40.6%)
HOSPITAL 2,305 (9.7%)
NO INFORMATION 334 (1.4%)
UNKNOWN 39 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 30 (0.1%)
OTHER 28 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Programmer, Pacemaker, 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 (23,727 here).

Fastener 23,725 Counter, Differential Cell 23,410 Thoracolumbosacral Pedicle Screw System 24,083 Stent, Coronary 23,266

Similar death-typed counts

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

Catheter And Tip, Suction 14 Display, Cathode-Ray Tube, Medical 14 Endoscopic Tissue Approximation Device 14 Glucose Oxidase, Glucose 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.