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2026 data FDA MAUDE openFDA

Pacemaker Lead Adaptor

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 Lead Adaptor LIGHT-BOOK · MAUDE

#750 of 1000 · 733 reports · 1992–2026

  • BOOK 733 reports
  • RANK #750 of 1000
  • DEATH 40 death-typed
  • INJ 454 injury-typed
  • MALF 227 malfunction
  • SPAN 1992–2026
  • PEAK 1994: 75
  • PHOTO Culture Media

Nearest event-volume peer: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (0 report gap)

Pacemaker Lead Adaptor sits #750 of 1000 among tracked device types with 733 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 5.5% corpus 1.5% · above corpus mean (+3.9 pp)
  • INJ 61.9% corpus 30.4% · above corpus mean (+31.5 pp)
  • MALF 31.0% corpus 64.5% · below corpus mean (-33.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 43% of coded problems · Lead manufacturer MEDTRONIC, INC. accounts for 44% of manufacturer-tagged reports · Top event location HOSPITAL is 36% of location-tagged rows .

Pacemaker Lead Adaptor in the event-volume neighbourhood

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

reports

What this shows Pacemaker Lead Adaptor carries 733 MAUDE reports, ranked #750 of 1000.

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

Event Types

Injury 454 (61.9%)
Malfunction 227 (31.0%)
Death 40 (5.5%)
7 (1.0%)
Other 5 (0.7%)

Patient Outcomes

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

Required Intervention 265 (27.7%)
R 158 (16.5%)
Hospitalization 156 (16.3%)
133 (13.9%)
Other 122 (12.7%)
Death 39 (4.1%)
L 35 (3.7%)
H 30 (3.1%)
Life Threatening 13 (1.4%)
O 2 (0.2%)
Invalid Data 2 (0.2%)
C 1 (0.1%)
S 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 127
Over-Sensing 22
High Capture Threshold 18
High impedance 16
Signal Artifact/Noise 15
Ambient Noise Problem 10
Failure to Capture 9
Low impedance 9
Connection Problem 8
Impedance Problem 8
Insufficient Information 8
Fracture 7
Break 6
Capturing Problem 6
Device Sensing Problem 5
Appropriate Term/Code Not Available 4
Degraded 4
Pacing Problem 4
Material Integrity Problem 3
Under-Sensing 3

Yearly Trend

92
1992: 21
93
1993: 48
94
1994: 75
95
1995: 30
96
1996: 17
97
1997: 26
98
1998: 13
99
1999: 4
00
2000: 4
01
2001: 9
02
2002: 6
03
2003: 6
04
2004: 7
05
2005: 5
06
2006: 5
07
2007: 8
08
2008: 8
09
2009: 8
10
2010: 36
11
2011: 18
12
2012: 19
13
2013: 30
14
2014: 21
15
2015: 41
16
2016: 20
17
2017: 16
18
2018: 29
19
2019: 34
20
2020: 19
21
2021: 23
22
2022: 25
23
2023: 28
24
2024: 35
25
2025: 32
26
2026: 7

Related Entities for Pacemaker Lead Adaptor

Top Manufacturers

MEDTRONIC, INC. 131
MPRI 60
CPI - DEL CARIBE 53
MEDTRONIC 34
CARDIAC PACEMAKERS 18

Event Locations

HOSPITAL 265 (36.2%)
229 (31.2%)
I 150 (20.5%)
OTHER 21 (2.9%)
UNKNOWN 21 (2.9%)
INVALID DATA 19 (2.6%)
HOME 11 (1.5%)
NOT APPLICABLE 6 (0.8%)
NO INFORMATION 5 (0.7%)
OUTPATIENT TREATMENT FACILITY 3 (0.4%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.3%)
NURSING HOME 1 (0.1%)

Compare MEDTRONIC, INC. vs MPRI →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Pacemaker Lead Adaptor, 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 (733 here).

Culture Media 733 Extractor, Vacuum, Fetal 730 Gas Control Unit, Cardiopulmonary Bypass 729 Needle, Fistula 737

Similar death-typed counts

Nearest other device types by death-typed report count (40 here), distinct from the volume row.

Appliance, Fixation, Spinal Interlaminal 40 Applier, Surgical, Clip 40 Prosthesis, Hip, Femoral, Resurfacing 40 System, Image Processing, Radiological 40

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

Disclaimer: MAUDE figures for Pacemaker Lead Adaptor 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 Lead Adaptor; 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.