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
#181 of 1000 · 13,091 reports · 2004–2026
- BOOK 13,091 reports
- RANK #181 of 1000
- DEATH 266 death-typed
- INJ 7,230 injury-typed
- MALF 5,574 malfunction
- SPAN 2004–2026
- PEAK 2025: 1,957
- PHOTO Bone Cement
Nearest event-volume peer: Bone Cement (52 report gap)
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) sits #181 of 1000 among tracked device types with 13,091 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 →
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 2.0% corpus 1.5% · above corpus mean (+0.5 pp)
- INJ 55.2% corpus 30.4% · above corpus mean (+24.8 pp)
- MALF 42.6% corpus 64.5% · below corpus mean (-21.9 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 22% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 40% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .
Pulse Generator in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Oximeter
Oximeter
13,424 reports
- Pulse Generat… (this)
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
13,091 reports
- Bone Cement
Bone Cement
13,039 reports
- Filler
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
13,013 reports
- Pulse-Generat…
Pulse-Generator, Pacemaker, External
12,771 reports
- Catheter
Catheter, Steerable
12,715 reports
What this shows Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) carries 13,091 MAUDE reports, ranked #181 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
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 similar MAUDE profiles
Two openFDA-derived peer sets for Pulse Generator, 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 (13,091 here).
Similar death-typed counts
Nearest other device types by death-typed report count (266 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.