2026 data FDA MAUDE openFDA

Analyzer, Pacemaker Generator Function

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 MAUDE casebook

openFDA event book Analyzer, Pacemaker Generator Function LIGHT-BOOK · MAUDE

#355 of 1000 · 3,813 reports · 1996–2026

  • BOOK 3,813 reports
  • RANK #355 of 1000
  • DEATH 3 death-typed
  • INJ 153 injury-typed
  • MALF 3,655 malfunction
  • SPAN 1996–2026
  • PEAK 2025: 1,196
  • PHOTO Transducer

Nearest event-volume peer: Transducer, Blood-Pressure, Extravascular (11 report gap)

Analyzer, Pacemaker Generator Function sits #355 of 1000 among tracked device types with 3,813 MAUDE reports spanning 1996–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 4.0% corpus 30.4% · below corpus mean (-26.4 pp)
  • MALF 95.9% corpus 64.5% · above corpus mean (+31.3 pp)

Lead product-problem code Computer Software Problem is 28% of coded problems · Lead manufacturer MEDTRONIC, INC. accounts for 92% of manufacturer-tagged reports · Top event location is 82% of location-tagged rows .

Analyzer, Pacemaker Generator Function in the event-volume neighbourhood

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

reports

What this shows Analyzer, Pacemaker Generator Function carries 3,813 MAUDE reports, ranked #355 of 1000.

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

Event Types

Malfunction 3,655 (95.9%)
Injury 153 (4.0%)
Death 3 (0.1%)
1 (0.0%)
Other 1 (0.0%)

Patient Outcomes

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

3,616 (93.3%)
Required Intervention 94 (2.4%)
Life Threatening 66 (1.7%)
R 37 (1.0%)
L 20 (0.5%)
Hospitalization 18 (0.5%)
Other 12 (0.3%)
H 9 (0.2%)
Death 2 (0.1%)
D 1 (0.0%)
O 1 (0.0%)

Top Product Problems

Computer Software Problem 1,714
Computer Operating System Problem 1,093
Communication or Transmission Problem 965
Display or Visual Feedback Problem 908
Output Problem 279
Data Problem 207
Device Difficult to Program or Calibrate 135
Failure to Interrogate 126
Capturing Problem 115
Pacing Problem 91
Device Sensing Problem 87
Application Program Problem 84
Inadequate User Interface 63
Device Displays Incorrect Message 40
Wireless Communication Problem 29
Problem with Software Installation 26
Failure to Capture 21
Power Problem 20
Signal Artifact/Noise 17
Impedance Problem 16

Yearly Trend

96
1996: 16
97
1997: 28
98
1998: 16
99
1999: 1
00
2000: 1
01
2001: 1
04
2004: 1
06
2006: 6
10
2010: 2
11
2011: 1
14
2014: 1
17
2017: 34
18
2018: 22
19
2019: 139
20
2020: 188
21
2021: 635
22
2022: 218
23
2023: 215
24
2024: 1,077
25
2025: 1,196
26
2026: 15

Related Entities for Analyzer, Pacemaker Generator Function

Event Locations

3,112 (81.6%)
I 647 (17.0%)
INVALID DATA 31 (0.8%)
HOME 10 (0.3%)
HOSPITAL 9 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.1%)

Compare MEDTRONIC, INC. vs PLEXUS MANUFACTURING SDN. BHD →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Analyzer, Pacemaker Generator Function, 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 (3,813 here).

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Disclaimer: MAUDE figures for Analyzer, Pacemaker Generator Function 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 Analyzer, Pacemaker Generator Function; 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.