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2026 data FDA MAUDE openFDA FDA Class II

Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

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 II (moderate risk, special controls required), regulated under 21 CFR §870.5550 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Pacemaker, Cardiac, External Transcutaneous LIGHT-BOOK · MAUDE

#831 of 1000 · 599 reports · 1992–2026

  • BOOK 599 reports
  • RANK #831 of 1000
  • DEATH 19 death-typed
  • INJ 40 injury-typed
  • MALF 529 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 93
  • PHOTO Drill

Nearest event-volume peer: Drill, Dental, Intraoral (0 report gap)

Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) sits #831 of 1000 among tracked device types with 599 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 sit below the device-type norm

Pacemaker, Cardiac, External Transcutaneous carries 6.7% INJURY-coded reports, 23.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.2% corpus 1.5% · above corpus mean (+1.7 pp)
  • INJ 6.7% corpus 30.3% · below corpus mean (-23.6 pp)
  • MALF 88.3% corpus 64.8% · above corpus mean (+23.5 pp)

Lead product-problem code Pacing Problem is 33% of coded problems · Lead manufacturer ZOLL MEDICAL CORPORATION accounts for 51% of manufacturer-tagged reports · Top event location I is 47% of location-tagged rows .

Pacemaker, Cardiac, External Transcutaneous in the event-volume neighbourhood

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

reports

What this shows Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) carries 599 MAUDE reports, ranked #831 of 1000.

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

Event Types

Malfunction 529 (88.3%)
Injury 40 (6.7%)
Death 19 (3.2%)
Other 8 (1.3%)
3 (0.5%)

Patient Outcomes

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

362 (59.2%)
Other 187 (30.6%)
Required Intervention 22 (3.6%)
Death 20 (3.3%)
O 5 (0.8%)
Life Threatening 5 (0.8%)
R 4 (0.7%)
L 2 (0.3%)
S 2 (0.3%)
Hospitalization 2 (0.3%)
Invalid Data 1 (0.2%)

Top Product Problems

Pacing Problem 158
Failure to Power Up 41
Device Displays Incorrect Message 40
Replace 28
Device Operates Differently Than Expected 24
Failure to Capture 19
No Device Output 19
Failure of Device to Self-Test 15
Gel Leak 14
No Display/Image 14
Material Separation 13
Pacing Inadequately 13
Loss of Power 12
Output Problem 11
Battery failure 10
Defibrillation/Stimulation Problem 10
Failure to Charge 10
Peeled/Delaminated 10
Electrical /Electronic Property Problem 9
Other (for use when an appropriate device code cannot be identified) 9

Yearly Trend

92
1992: 17
93
1993: 11
94
1994: 7
95
1995: 1
96
1996: 5
97
1997: 23
98
1998: 45
99
1999: 38
00
2000: 25
01
2001: 25
02
2002: 10
03
2003: 6
04
2004: 9
05
2005: 9
06
2006: 5
07
2007: 7
08
2008: 5
09
2009: 3
10
2010: 7
11
2011: 3
12
2012: 8
13
2013: 11
14
2014: 2
15
2015: 41
16
2016: 49
17
2017: 15
18
2018: 64
19
2019: 93
20
2020: 19
21
2021: 22
23
2023: 6
24
2024: 4
25
2025: 2
26
2026: 2

Reports fell to 2 in 2025, down from an average of 5 in the two years before.

Related Entities for Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

Top Manufacturers

ZOLL MEDICAL CORPORATION 249
ZOLL MEDICAL CORP. 110
COVIDIEN 79
PHILIPS MEDICAL SYSTEMS 17
ZOLL MEDICAL CORP 14
CARDINAL HEALTH 8
MEDTRONIC 8
PHYSIO-CONTROL, INC. 8

Event Locations

I 284 (47.4%)
179 (29.9%)
HOSPITAL 105 (17.5%)
OTHER 9 (1.5%)
OUTPATIENT TREATMENT FACILITY 6 (1.0%)
NO INFORMATION 5 (0.8%)
INVALID DATA 4 (0.7%)
HOME 3 (0.5%)
NURSING HOME 2 (0.3%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)
UNKNOWN 1 (0.2%)

Compare ZOLL MEDICAL CORPORATION vs ZOLL MEDICAL CORP. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pacemaker, Cardiac, External Transcutaneous: 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 (599 here).

Drill, Dental, Intraoral 599 Neurosurgical Paddie 600 Device, Anastomotic, Microvascular 601 Suture, Nonabsorbable 601

Similar death-typed counts

Nearest other device types by death-typed report count (19 here), distinct from the volume row.

Electrode, Electrosurgical 19 Recorder, Event, Implantable Cardiac, 19 Sleeve, Limb, Compressible 19 Accelerator, Linear, Medical 20

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

Disclaimer: MAUDE figures for Pacemaker, Cardiac, External Transcutaneous 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 Pacemaker, Cardiac, External Transcutaneous; 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.