Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
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 Pulse Generator MID-BOOK · MAUDE
#176 of 1000 · 14,494 reports · 2004–2026
- BOOK 14,494 reports
- RANK #176 of 1000
- DEATH 272 death-typed
- INJ 7,881 injury-typed
- MALF 6,320 malfunction
- SPAN 2004–2026
- PEAK 2025: 1,956
- PHOTO Device
Nearest event-volume peer: Device, Vascular, For Promoting Embolization (71 report gap)
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) sits #176 of 1000 among tracked device types with 14,494 MAUDE reports spanning 2004–2026. 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 →
Injury-coded reports run above the device-type norm
Pulse Generator carries 54.4% INJURY-coded reports, 24.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.9% corpus 1.5% · near corpus mean (+0.4 pp)
- INJ 54.4% corpus 30.3% · above corpus mean (+24.1 pp)
- MALF 43.6% corpus 64.8% · below corpus mean (-21.2 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 20% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 44% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .
Pulse Generator in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Lift
Lift, Patient, Non-Ac-Powered
14,697 reports
- Appliance
Appliance, Fixation, Spinal Interlaminal
14,567 reports
- Pulse Generat… (this)
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
14,494 reports
- Device
Device, Vascular, For Promoting Embolization
14,423 reports
- Set
Set, I.V. Fluid Transfer
14,331 reports
- Lens
Lens, Multifocal Intraocular
14,298 reports
What this shows Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) carries 14,494 MAUDE reports, ranked #176 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 in 2025 (1,956) held close to the prior two-year average of 1,494.
Related Entities for Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Top Manufacturers
Event Locations
Compare BOSTON SCIENTIFIC CORPORATION vs MEDTRONIC EUROPE SARL →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Pulse Generator: 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 (14,494 here).
Similar death-typed counts
Nearest other device types by death-typed report count (272 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Pulse Generator 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 Pulse Generator; 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.