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2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.3620 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Pacemaker Lead Adaptor LIGHT-BOOK · MAUDE

#764 of 1000 · 741 reports · 1992–2026

  • BOOK 741 reports
  • RANK #764 of 1000
  • DEATH 40 death-typed
  • INJ 457 injury-typed
  • MALF 232 malfunction
  • SPAN 1992–2026
  • PEAK 1994: 75
  • PHOTO Handpiece

Nearest event-volume peer: Handpiece, Direct Drive, Ac-Powered (5 report gap)

Pacemaker Lead Adaptor sits #764 of 1000 among tracked device types with 741 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 →

Malfunction reports sit below the device-type norm

Pacemaker Lead Adaptor carries 31.3% MALFUNCTION-coded reports, 33.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 5.4% corpus 1.5% · above corpus mean (+3.9 pp)
  • INJ 61.7% corpus 30.3% · above corpus mean (+31.4 pp)
  • MALF 31.3% corpus 64.8% · below corpus mean (-33.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 27% of coded problems · Lead manufacturer MEDTRONIC, INC. accounts for 45% 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 741 MAUDE reports, ranked #764 of 1000.

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

Event Types

Injury 457 (61.7%)
Malfunction 232 (31.3%)
Death 40 (5.4%)
7 (0.9%)
Other 5 (0.7%)

Patient Outcomes

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

Required Intervention 266 (27.7%)
R 158 (16.4%)
Hospitalization 156 (16.2%)
136 (14.1%)
Other 122 (12.7%)
Death 39 (4.1%)
L 35 (3.6%)
H 31 (3.2%)
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 149
High impedance 48
Over-Sensing 32
Appropriate Device Problem Term/Code Not Available 30
Failure to Capture 29
Fracture 29
Signal Artifact/Noise 26
Material Perforation 22
High Capture Threshold 21
Insufficient Device Problem Information 20
Low impedance 20
Material Integrity Problem 19
Break 17
Unknown (for use when the device problem is not known) 17
Connection Problem 13
Impedance Problem 13
Ambient Noise Problem 10
Device Damaged Prior to Use 10
Explanted 10
Capturing Problem 9

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: 15

Reports in 2025 (32) held close to the prior two-year average of 32.

Related Entities for Pacemaker Lead Adaptor

Top Manufacturers

MEDTRONIC, INC. 133
MPRI 60
CPI - DEL CARIBE 53
MEDTRONIC 34
CARDIAC PACEMAKERS 18

Event Locations

HOSPITAL 265 (35.8%)
237 (32.0%)
I 150 (20.2%)
OTHER 21 (2.8%)
UNKNOWN 21 (2.8%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pacemaker Lead Adaptor: 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 (741 here).

Handpiece, Direct Drive, Ac-Powered 736 Implanted Brain Stimulator For Epilepsy 746 Device, Intravascular Catheter Securement 749 Osteotome 749

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 Walker, Mechanical 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.