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2026 data FDA MAUDE openFDA FDA Class III

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.

OpenFDA device adverse-event casebook.

FDA Class III (highest risk, premarket approval required), regulated under 21 CFR §870.3610 (Cardiovascular panel).

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FDA MAUDE casebook

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

#62 of 1000 · 57,769 reports · 1991–2026

  • BOOK 57,769 reports
  • RANK #62 of 1000
  • DEATH 1,952 death-typed
  • INJ 31,460 injury-typed
  • MALF 23,791 malfunction
  • SPAN 1991–2026
  • PEAK 2011: 6,050
  • PHOTO Screw, Fixation, Bone

Nearest event-volume peer: Screw, Fixation, Bone (857 report gap)

Implantable Pacemaker Pulse-Generator sits #62 of 1000 among tracked device types with 57,769 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 →

Injury-coded reports run above the device-type norm

Implantable Pacemaker Pulse-Generator carries 54.5% INJURY-coded reports, 24.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.4% corpus 1.5% · above corpus mean (+1.9 pp)
  • INJ 54.5% corpus 30.3% · above corpus mean (+24.2 pp)
  • MALF 41.2% corpus 64.8% · below corpus mean (-23.6 pp)

Lead product-problem code Premature Discharge of Battery is 10% 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 57,769 MAUDE reports, ranked #62 of 1000.

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

Event Types

Injury 31,460 (54.5%)
Malfunction 23,791 (41.2%)
Death 1,952 (3.4%)
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 18,459 (26.6%)
16,198 (23.3%)
Hospitalization 10,253 (14.8%)
Other 9,974 (14.4%)
R 9,623 (13.9%)
Death 1,920 (2.8%)
L 1,085 (1.6%)
H 695 (1.0%)
O 568 (0.8%)
Life Threatening 560 (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

Premature Discharge of Battery 4,829
Adverse Event Without Identified Device or Use Problem 3,741
Pacing Problem 3,707
Failure to Capture 3,651
Pacemaker Found in Back-Up Mode 3,537
Failure to Interrogate 3,505
Over-Sensing 3,114
Low Battery 3,050
No Device Output 2,769
Other (for use when an appropriate device code cannot be identified) 2,612
High impedance 2,205
Unknown (for use when the device problem is not known) 1,997
Explanted 1,907
Difficult to Interrogate 1,772
Appropriate Device Problem Term/Code Not Available 1,444
Telemetry Discrepancy 1,324
Premature Elective Replacement Indicator 1,279
Device Displays Incorrect Message 1,231
Normal 1,157
Malfunction 1,075

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: 2,180
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: 561
22
2022: 784
23
2023: 922
24
2024: 773
25
2025: 817
26
2026: 593

Reports in 2025 (817) held close to the prior two-year average of 848.

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. 5,651
MEDTRONIC S.A. 3,912
CARDIAC PACEMAKERS, INC 3,353
ST. JUDE MEDICAL, INC., CRMD 3,283
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2,929
GUIDANT CRM CLONMEL IRELAND 2,162
CARDIAC PACEMAKERS 1,848
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1,055

Event Locations

HOSPITAL 33,356 (57.7%)
11,448 (19.8%)
I 7,047 (12.2%)
OTHER 3,793 (6.6%)
OUTPATIENT TREATMENT FACILITY 654 (1.1%)
INVALID DATA 586 (1.0%)
HOME 435 (0.8%)
UNKNOWN 149 (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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Implantable Pacemaker Pulse-Generator: 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 (57,769 here).

Screw, Fixation, Bone 58,626 Suture 56,265 Pacemaker/Icd/Crt Non-Implanted Components 55,908 Endoscopic Video Imaging System/Component 61,453

Similar death-typed counts

Nearest other device types by death-typed report count (1,952 here), distinct from the volume row.

Monitor, Physiological, Patient 1,909 Stimulator 1,904 Heart-Valve, Non-Allograft Tissue 2,037 Drug Eluting Permanent Left Ventricular Pac… 1,856

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.