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2026 data FDA MAUDE openFDA

Implantable Pacemaker Pulse-Generator

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

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FDA MAUDE casebook

openFDA event book Implantable Pacemaker Pulse-Generator MID-BOOK · MAUDE

#59 of 1000 · 57,343 reports · 1991–2026

  • BOOK 57,343 reports
  • RANK #59 of 1000
  • DEATH 1,915 death-typed
  • INJ 31,252 injury-typed
  • MALF 23,610 malfunction
  • SPAN 1991–2026
  • PEAK 2011: 6,050
  • PHOTO Screw, Fixation, Bone

Nearest event-volume peer: Screw, Fixation, Bone (377 report gap)

Implantable Pacemaker Pulse-Generator sits #59 of 1000 among tracked device types with 57,343 MAUDE reports spanning 1991–2026. 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 3.3% corpus 1.5% · above corpus mean (+1.8 pp)
  • INJ 54.5% corpus 30.4% · above corpus mean (+24.1 pp)
  • MALF 41.2% corpus 64.5% · below corpus mean (-23.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 22% of coded problems · Lead manufacturer ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION accounts for 21% of manufacturer-tagged reports · Top event location HOSPITAL is 58% of location-tagged rows .

Implantable Pacemaker Pulse-Generator in the event-volume neighbourhood

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

reports

What this shows Implantable Pacemaker Pulse-Generator carries 57,343 MAUDE reports, ranked #59 of 1000.

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

Event Types

Injury 31,252 (54.5%)
Malfunction 23,610 (41.2%)
Death 1,915 (3.3%)
Other 385 (0.7%)
181 (0.3%)

Patient Outcomes

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

Required Intervention 18,375 (26.7%)
16,048 (23.3%)
Hospitalization 10,202 (14.8%)
Other 9,965 (14.5%)
R 9,559 (13.9%)
Death 1,883 (2.7%)
L 1,065 (1.5%)
H 622 (0.9%)
O 568 (0.8%)
Life Threatening 530 (0.8%)
S 37 (0.1%)
Disability 22 (0.0%)
Invalid Data 8 (0.0%)
Congenital Anomaly 7 (0.0%)
D 6 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,389
Over-Sensing 1,024
Device Dislodged or Dislocated 935
Signal Artifact/Noise 718
Failure to Capture 648
Premature Discharge of Battery 630
High Capture Threshold 521
High impedance 451
Appropriate Term/Code Not Available 419
Pacing Problem 366
Failure to Interrogate 333
Under-Sensing 318
Inappropriate/Inadequate Shock/Stimulation 294
Fracture 292
Device Sensing Problem 277
Pacemaker Found in Back-Up Mode 267
Break 257
Impedance Problem 256
Capturing Problem 237
Low impedance 221

Yearly Trend

91
1991: 1
92
1992: 27
93
1993: 40
94
1994: 107
95
1995: 82
96
1996: 429
97
1997: 3,119
98
1998: 1,737
99
1999: 1,126
00
2000: 1,991
01
2001: 1,248
02
2002: 976
03
2003: 881
04
2004: 687
05
2005: 625
06
2006: 2,181
07
2007: 2,407
08
2008: 2,649
09
2009: 3,750
10
2010: 4,186
11
2011: 6,050
12
2012: 3,709
13
2013: 2,682
14
2014: 5,604
15
2015: 1,022
16
2016: 542
17
2017: 1,047
18
2018: 2,070
19
2019: 1,799
20
2020: 546
21
2021: 560
22
2022: 784
23
2023: 922
24
2024: 773
25
2025: 819
26
2026: 165

Related Entities for Implantable Pacemaker Pulse-Generator

Top Manufacturers

ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 8,530
MEDTRONIC MED REL, INC. 7,838
MEDTRONIC, INC. 5,492
MEDTRONIC S.A. 3,912
CARDIAC PACEMAKERS, INC 3,353
ST. JUDE MEDICAL, INC., CRMD 3,283
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2,924
GUIDANT CRM CLONMEL IRELAND 2,163
CARDIAC PACEMAKERS 1,848
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1,055

Event Locations

HOSPITAL 33,356 (58.2%)
11,021 (19.2%)
I 7,047 (12.3%)
OTHER 3,793 (6.6%)
OUTPATIENT TREATMENT FACILITY 654 (1.1%)
INVALID DATA 586 (1.0%)
HOME 435 (0.8%)
UNKNOWN 150 (0.3%)
NOT APPLICABLE 91 (0.2%)
NO INFORMATION 65 (0.1%)
CLINIC - WALK IN, OTHER 61 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 31 (0.1%)
PATIENT'S HOME 17 (0.0%)
NURSING HOME 14 (0.0%)
AMBULATORY SURGICAL FACILITY 11 (0.0%)
33 2 (0.0%)
AMBULATORY HEALTH CARE FACILITY 1 (0.0%)
CATHETERIZATION SUITE 1 (0.0%)
EMERGENCY ROOM 1 (0.0%)
EXAMINATION ROOM 1 (0.0%)
LONG-TERM CARE FACILITY 1 (0.0%)
PUBLIC VENUE 1 (0.0%)
REHABILITATION CENTER 1 (0.0%)
SCHOOL 1 (0.0%)
X 1 (0.0%)

Compare ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION vs MEDTRONIC MED REL, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Implantable Pacemaker Pulse-Generator, 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 (57,343 here).

Screw, Fixation, Bone 56,966 Gastroscope And Accessories, Flexible/Rigid 56,447 Endoscopic Video Imaging System/Component 53,347 Colonoscope And Accessories, Flexible/Rigid 62,094

Similar death-typed counts

Nearest other device types by death-typed report count (1,915 here), distinct from the volume row.

Monitor, Physiological, Patient 1,857 Drug Eluting Permanent Left Ventricular Pac… 1,840 Heart-Valve, Non-Allograft Tissue 1,996 Implantable Pulse Generator, Pacemaker 1,816

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

Disclaimer: MAUDE figures for Implantable Pacemaker Pulse-Generator 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 Implantable Pacemaker Pulse-Generator; 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.