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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#27 of 1000 · 147,576 reports · 1992–2026

  • BOOK 147,576 reports
  • RANK #27 of 1000
  • DEATH 1,816 death-typed
  • INJ 86,175 injury-typed
  • MALF 59,548 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 14,936
  • PHOTO Integrated Continuous…

Nearest event-volume peer: Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (639 report gap)

Implantable Pulse Generator, Pacemaker (Non-Crt) sits #27 of 1000 among tracked device types with 147,576 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 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 58.4% corpus 30.4% · above corpus mean (+28.0 pp)
  • MALF 40.4% corpus 64.5% · below corpus mean (-24.2 pp)

Lead product-problem code Premature Discharge of Battery is 19% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 42% of manufacturer-tagged reports · Top event location is 48% 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 147,576 MAUDE reports, ranked #27 of 1000.

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

Event Types

Injury 86,175 (58.4%)
Malfunction 59,548 (40.4%)
Death 1,816 (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.

58,560 (24.5%)
R 51,823 (21.7%)
Hospitalization 51,705 (21.7%)
Required Intervention 28,359 (11.9%)
L 27,823 (11.7%)
H 10,700 (4.5%)
Other 4,239 (1.8%)
Life Threatening 2,461 (1.0%)
Death 1,763 (0.7%)
O 1,040 (0.4%)
S 47 (0.0%)
D 35 (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 27,643
Adverse Event Without Identified Device or Use Problem 27,468
Over-Sensing 10,941
High impedance 10,317
Device Displays Incorrect Message 10,099
Pacing Problem 7,039
Failure to Capture 6,124
Incorrect, Inadequate or Imprecise Result or Readings 6,016
Defective Device 5,488
Battery Problem 5,069
Signal Artifact/Noise 4,443
High Capture Threshold 3,098
Pacemaker Found in Back-Up Mode 3,039
Ambient Noise Problem 3,035
Device Dislodged or Dislocated 2,914
Under-Sensing 2,743
Device Operates Differently Than Expected 2,581
Material Integrity Problem 2,540
Capturing Problem 2,510
Failure to Interrogate 2,214

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: 805
10
2010: 678
11
2011: 684
12
2012: 1,087
13
2013: 5,164
14
2014: 9,400
15
2015: 9,422
16
2016: 12,354
17
2017: 11,643
18
2018: 14,936
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: 12,073
26
2026: 3,197

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

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 56,410
GUIDANT CRM CLONMEL IRELAND 28,116
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 20,432
CPI - DEL CARIBE 6,657
ABBOTT 5,822
MEDTRONIC MILACA, INC. 5,607
MPRI 4,875
ST. JUDE MEDICAL, INC., CRMD 2,488
MEDTRONIC, INC. 2,145
IPG MFG SWITZERLAND 1,982

Event Locations

71,569 (48.5%)
I 69,957 (47.4%)
HOSPITAL 4,786 (3.2%)
OTHER 662 (0.4%)
NO INFORMATION 322 (0.2%)
OUTPATIENT TREATMENT FACILITY 176 (0.1%)
NOT APPLICABLE 46 (0.0%)
HOME 38 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Implantable Pulse Generator, 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 (147,576 here).

Integrated Continuous Glucose Monitoring Sy… 146,937 Wearable Automated External Defibrillator 143,491 Ventricular Bypass 153,365 Prosthesis 153,958

Similar death-typed counts

Nearest other device types by death-typed report count (1,816 here), distinct from the volume row.

Stimulator 1,806 Drug Eluting Permanent Left Ventricular Pac… 1,840 Monitor, Physiological, Patient 1,857 Stent, Coronary 1,758

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.