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2026 data FDA MAUDE openFDA

Permanent Pacemaker Electrode

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 Permanent Pacemaker Electrode HEAVY-BOOK · MAUDE

#13 of 1000 · 313,884 reports · 1992–2026

  • BOOK 313,884 reports
  • RANK #13 of 1000
  • DEATH 9,301 death-typed
  • INJ 168,493 injury-typed
  • MALF 135,488 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 34,542
  • PHOTO Sensor

Nearest event-volume peer: Sensor, Glucose, Invasive, Non-Adjunctive (2,178 report gap)

Permanent Pacemaker Electrode sits #13 of 1000 among tracked device types with 313,884 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 3.0% corpus 1.5% · above corpus mean (+1.4 pp)
  • INJ 53.7% corpus 30.4% · above corpus mean (+23.2 pp)
  • MALF 43.2% corpus 64.5% · below corpus mean (-21.3 pp)

Lead product-problem code Under-Sensing is 16% of coded problems · Lead manufacturer MPRI accounts for 54% of manufacturer-tagged reports · Top event location is 45% of location-tagged rows .

Permanent Pacemaker Electrode in the event-volume neighbourhood

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

reports

What this shows Permanent Pacemaker Electrode carries 313,884 MAUDE reports, ranked #13 of 1000.

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

Event Types

Injury 168,493 (53.7%)
Malfunction 135,488 (43.2%)
Death 9,301 (3.0%)
Other 380 (0.1%)
222 (0.1%)

Patient Outcomes

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

117,175 (26.2%)
Hospitalization 95,970 (21.5%)
R 93,605 (21.0%)
Required Intervention 63,803 (14.3%)
Other 22,383 (5.0%)
H 20,053 (4.5%)
L 17,950 (4.0%)
Death 8,906 (2.0%)
Life Threatening 4,702 (1.1%)
O 1,583 (0.4%)
D 152 (0.0%)
S 69 (0.0%)
Congenital Anomaly 33 (0.0%)
Disability 22 (0.0%)
C 10 (0.0%)
Invalid Data 9 (0.0%)

Top Product Problems

Under-Sensing 47,833
Adverse Event Without Identified Device or Use Problem 32,705
Over-Sensing 31,908
High Capture Threshold 30,924
High impedance 19,367
Device Dislodged or Dislocated 18,813
Failure to Capture 15,747
Signal Artifact/Noise 13,085
Pacing Problem 11,122
Impedance Problem 10,176
Fracture 9,940
Capturing Problem 8,800
Low impedance 8,571
Decreased Sensitivity 7,143
Electrical /Electronic Property Problem 6,070
Positioning Problem 6,063
Appropriate Term/Code Not Available 3,917
Break 3,826
Unstable Capture Threshold 3,761
Activation, Positioning or Separation Problem 3,746

Yearly Trend

92
1992: 13
93
1993: 35
94
1994: 149
95
1995: 290
96
1996: 725
97
1997: 3,268
98
1998: 2,259
99
1999: 871
00
2000: 1,125
01
2001: 1,203
02
2002: 1,145
03
2003: 1,118
04
2004: 1,355
05
2005: 1,491
06
2006: 4,530
07
2007: 5,401
08
2008: 6,469
09
2009: 7,565
10
2010: 14,285
11
2011: 12,555
12
2012: 12,230
13
2013: 10,102
14
2014: 13,324
15
2015: 11,071
16
2016: 11,839
17
2017: 11,495
18
2018: 15,209
19
2019: 16,812
20
2020: 17,859
21
2021: 18,442
22
2022: 19,444
23
2023: 34,542
24
2024: 25,690
25
2025: 25,909
26
2026: 4,064

Related Entities for Permanent Pacemaker Electrode

Top Manufacturers

MPRI 154,713
MEDTRONIC PUERTO RICO, INC. 38,538
MEDTRONIC SINGAPORE OPERATIONS 23,844
MEDTRONIC PUERTO RICO VILLALBA 13,917
CPI - DEL CARIBE 13,267
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 12,982
BOSTON SCIENTIFIC CORPORATION 11,097
MEDTRONIC, INC. 7,734
CARDIAC PACEMAKERS, INC 7,092
MEDTRONIC 3,970

Event Locations

141,579 (45.1%)
I 95,554 (30.4%)
HOSPITAL 70,358 (22.4%)
OTHER 3,283 (1.0%)
OUTPATIENT TREATMENT FACILITY 986 (0.3%)
HOME 569 (0.2%)
INVALID DATA 418 (0.1%)
NO INFORMATION 412 (0.1%)
NOT APPLICABLE 292 (0.1%)
UNKNOWN 170 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 83 (0.0%)
PATIENT'S HOME 72 (0.0%)
CLINIC - WALK IN, OTHER 50 (0.0%)
AMBULATORY SURGICAL FACILITY 28 (0.0%)
NURSING HOME 16 (0.0%)
HOSPICE 3 (0.0%)
X 3 (0.0%)
33 2 (0.0%)
CATHETERIZATION SUITE 1 (0.0%)
EXAMINATION ROOM 1 (0.0%)
LONG-TERM CARE FACILITY 1 (0.0%)
OPERATING ROOM 1 (0.0%)
OUTDOORS 1 (0.0%)
PUBLIC VENUE 1 (0.0%)

Compare MPRI vs MEDTRONIC PUERTO RICO, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Permanent Pacemaker Electrode, 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 (313,884 here).

Sensor, Glucose, Invasive, Non-Adjunctive 316,062 Sensor, Glucose, Invasive 280,884 Stimulator 362,034 Ventilator, Non-Continuous 265,078

Similar death-typed counts

Nearest other device types by death-typed report count (9,301 here), distinct from the volume row.

Implantable Cardioverter Defibrillator 10,004 Coronary Drug-Eluting Stent 11,160 Aortic Valve 7,440 System 7,020

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

Disclaimer: MAUDE figures for Permanent Pacemaker Electrode 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 Permanent Pacemaker Electrode; 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.