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2025 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#812 of 1000 · 597 reports · 1992–2025

  • BOOK 597 reports
  • RANK #812 of 1000
  • DEATH 19 death-typed
  • INJ 38 injury-typed
  • MALF 529 malfunction
  • SPAN 1992–2025
  • PEAK 2019: 93
  • PHOTO Drill

Nearest event-volume peer: Drill, Dental, Intraoral (1 report gap)

Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) sits #812 of 1000 among tracked device types with 597 MAUDE reports spanning 1992–2025. 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 3.2% corpus 1.5% · above corpus mean (+1.7 pp)
  • INJ 6.4% corpus 30.4% · below corpus mean (-24.1 pp)
  • MALF 88.6% corpus 64.5% · above corpus mean (+24.1 pp)

Lead product-problem code Pacing Problem is 41% of coded problems · Lead manufacturer ZOLL MEDICAL CORPORATION accounts for 51% of manufacturer-tagged reports · Top event location I is 48% 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 597 MAUDE reports, ranked #812 of 1000.

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

Event Types

Malfunction 529 (88.6%)
Injury 38 (6.4%)
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 (59.7%)
Other 187 (30.9%)
Required Intervention 21 (3.5%)
Death 20 (3.3%)
Life Threatening 5 (0.8%)
O 4 (0.7%)
R 3 (0.5%)
L 1 (0.2%)
S 1 (0.2%)
Hospitalization 1 (0.2%)
Invalid Data 1 (0.2%)

Top Product Problems

Pacing Problem 99
Device Displays Incorrect Message 24
Failure of Device to Self-Test 15
Gel Leak 14
Material Separation 13
Device Operates Differently Than Expected 12
Peeled/Delaminated 10
Output Problem 8
Sparking 6
Defibrillation/Stimulation Problem 5
Detachment of Device or Device Component 5
Arcing 4
Connection Problem 4
Delamination 4
Device Emits Odor 4
Failure to Capture 4
Appropriate Term/Code Not Available 3
Arcing of Electrodes 3
Electrical /Electronic Property Problem 3
Loss of or Failure to Bond 3

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

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
MEDTRONIC 8
PHYSIO-CONTROL, INC. 8
CARDINAL HEALTH 7

Event Locations

I 284 (47.6%)
178 (29.8%)
HOSPITAL 104 (17.4%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Pacemaker, Cardiac, External Transcutaneous, 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 (597 here).

Drill, Dental, Intraoral 598 Endoscope 596 Source, Brachytherapy, Radionuclide 599 Instrument, Ligature Passing And Knot Tying 600

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 Transducer, Pressure, Catheter Tip 19

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.