Pacemaker/Icd/Crt Non-Implanted Components
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 Pacemaker/Icd/Crt Non-Implanted Components MID-BOOK · MAUDE
#64 of 1000 · 55,908 reports · 2013–2026
- BOOK 55,908 reports
- RANK #64 of 1000
- DEATH 2 death-typed
- INJ 92 injury-typed
- MALF 55,813 malfunction
- SPAN 2013–2026
- PEAK 2026: 45,147
- PHOTO Suture
Nearest event-volume peer: Suture, Absorbable, Synthetic, Polyglycolic Acid (357 report gap)
Pacemaker/Icd/Crt Non-Implanted Components sits #64 of 1000 among tracked device types with 55,908 MAUDE reports spanning 2013–2026. 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 run above the device-type norm
Pacemaker/Icd/Crt Non-Implanted Components carries 99.8% MALFUNCTION-coded reports, 35.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 0.2% corpus 30.3% · below corpus mean (-30.1 pp)
- MALF 99.8% corpus 64.8% · above corpus mean (+35.0 pp)
Lead product-problem code Computer Operating System Problem is 47% of coded problems · Lead manufacturer MEDTRONIC, INC. accounts for 94% of manufacturer-tagged reports · Top event location is 99% of location-tagged rows .
Pacemaker/Icd/Crt Non-Implanted Components in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Screw
Screw, Fixation, Bone
58,626 reports
- Implantable P…
Implantable Pacemaker Pulse-Generator
57,769 reports
- Suture
Suture, Absorbable, Synthetic, Polyglycolic Acid
56,265 reports
- Pacemaker/Icd… (this)
Pacemaker/Icd/Crt Non-Implanted Components
55,908 reports
- Stimulator
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
52,959 reports
- Generator
Generator, Oxygen, Portable
52,785 reports
What this shows Pacemaker/Icd/Crt Non-Implanted Components carries 55,908 MAUDE reports, ranked #64 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 8,600 in 2025, up from an average of 767 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Pacemaker/Icd/Crt Non-Implanted Components
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Pacemaker/Icd/Crt Non-Implanted Components: 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 (55,908 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Pacemaker/Icd/Crt Non-Implanted Components 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/Icd/Crt Non-Implanted Components; 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.