PlainHospital
2026 data FDA MAUDE openFDA FDA Class III

Implantable Pulse Generator, Pacemaker (Non-Crt)

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Implantable Pulse Generator, Pacemaker HEAVY-BOOK · MAUDE

#28 of 1000 · 156,369 reports · 1992–2026

  • BOOK 156,369 reports
  • RANK #28 of 1000
  • DEATH 1,854 death-typed
  • INJ 89,886 injury-typed
  • MALF 64,592 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 14,935
  • PHOTO Ventricular Bypass

Nearest event-volume peer: Ventricular (Assist) Bypass (1,062 report gap)

Implantable Pulse Generator, Pacemaker (Non-Crt) sits #28 of 1000 among tracked device types with 156,369 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 →

Injury-coded reports run above the device-type norm

Implantable Pulse Generator, Pacemaker carries 57.5% INJURY-coded reports, 27.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 57.5% corpus 30.3% · above corpus mean (+27.2 pp)
  • MALF 41.3% corpus 64.8% · below corpus mean (-23.5 pp)

Lead product-problem code Premature Discharge of Battery is 20% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 45% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

Implantable Pulse Generator, Pacemaker in the event-volume neighbourhood

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

reports

What this shows Implantable Pulse Generator, Pacemaker (Non-Crt) carries 156,369 MAUDE reports, ranked #28 of 1000.

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

Event Types

Injury 89,886 (57.5%)
Malfunction 64,592 (41.3%)
Death 1,854 (1.2%)
25 (0.0%)
Other 12 (0.0%)

Patient Outcomes

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

62,742 (25.4%)
R 52,846 (21.4%)
Hospitalization 52,735 (21.3%)
Required Intervention 29,750 (12.0%)
L 27,831 (11.2%)
H 11,759 (4.8%)
Other 4,345 (1.8%)
Life Threatening 2,482 (1.0%)
Death 1,798 (0.7%)
O 1,058 (0.4%)
S 49 (0.0%)
D 37 (0.0%)
Congenital Anomaly 29 (0.0%)
Disability 12 (0.0%)
Invalid Data 2 (0.0%)
C 1 (0.0%)

Top Product Problems

Premature Discharge of Battery 34,601
Adverse Event Without Identified Device or Use Problem 30,099
High impedance 14,207
Over-Sensing 13,099
Device Displays Incorrect Message 12,504
Pacing Problem 8,715
Failure to Capture 8,351
Incorrect, Inadequate or Imprecise Result or Readings 6,641
Defective Device 5,526
Battery Problem 5,368
Pacemaker Found in Back-Up Mode 5,060
Signal Artifact/Noise 4,839
Device Operates Differently Than Expected 4,646
High Capture Threshold 4,015
Device Dislodged or Dislocated 3,606
Device Sensing Problem 3,445
Under-Sensing 3,212
Ambient Noise Problem 3,208
Low impedance 3,099
Capturing Problem 2,830

Yearly Trend

92
1992: 4
93
1993: 1
94
1994: 5
95
1995: 2
96
1996: 11
97
1997: 44
98
1998: 33
99
1999: 18
00
2000: 16
01
2001: 18
02
2002: 5
03
2003: 4
04
2004: 1
05
2005: 6
06
2006: 17
07
2007: 48
08
2008: 496
09
2009: 806
10
2010: 678
11
2011: 684
12
2012: 1,090
13
2013: 5,164
14
2014: 9,400
15
2015: 9,422
16
2016: 12,354
17
2017: 11,643
18
2018: 14,935
19
2019: 9,627
20
2020: 8,989
21
2021: 9,374
22
2022: 14,286
23
2023: 12,633
24
2024: 10,495
25
2025: 12,075
26
2026: 11,985

Reports in 2025 (12,075) held close to the prior two-year average of 11,564.

Related Entities for Implantable Pulse Generator, Pacemaker (Non-Crt)

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 64,010
GUIDANT CRM CLONMEL IRELAND 28,114
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 20,559
CPI - DEL CARIBE 6,657
ABBOTT 5,894
MEDTRONIC MILACA, INC. 5,607
MPRI 4,874
ST. JUDE MEDICAL, INC., CRMD 2,488
MEDTRONIC, INC. 2,192
IPG MFG SWITZERLAND 1,982

Event Locations

80,423 (51.4%)
I 69,879 (44.7%)
HOSPITAL 4,794 (3.1%)
OTHER 667 (0.4%)
NO INFORMATION 322 (0.2%)
OUTPATIENT TREATMENT FACILITY 176 (0.1%)
NOT APPLICABLE 46 (0.0%)
HOME 42 (0.0%)
UNKNOWN 7 (0.0%)
INVALID DATA 6 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
PATIENT'S HOME 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OUTDOORS 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs GUIDANT CRM CLONMEL IRELAND →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Implantable Pulse Generator, 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 (156,369 here).

Ventricular Bypass 157,431 Prosthesis 157,471 Wearable Automated External Defibrillator 148,775 System, Peritoneal, Automatic Delivery 164,500

Similar death-typed counts

Nearest other device types by death-typed report count (1,854 here), distinct from the volume row.

Drug Eluting Permanent Left Ventricular Pac… 1,856 System, Appendage Closure, Left Atrial 1,816 Stimulator 1,904 Monitor, Physiological, Patient 1,909

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

Disclaimer: MAUDE figures for Implantable Pulse Generator, 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 Implantable Pulse Generator, 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.