Analyzer, Pacemaker Generator Function
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 §870.3630 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Analyzer, Pacemaker Generator Function LIGHT-BOOK · MAUDE
#360 of 1000 · 3,843 reports · 1996–2026
- BOOK 3,843 reports
- RANK #360 of 1000
- DEATH 3 death-typed
- INJ 152 injury-typed
- MALF 3,686 malfunction
- SPAN 1996–2026
- PEAK 2025: 1,193
- PHOTO Covid-19 Multi-Analyt…
Nearest event-volume peer: Covid-19 Multi-Analyte Antigen Device (3 report gap)
Analyzer, Pacemaker Generator Function sits #360 of 1000 among tracked device types with 3,843 MAUDE reports spanning 1996–2026. 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
Analyzer, Pacemaker Generator Function carries 95.9% MALFUNCTION-coded reports, 31.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 4.0% corpus 30.3% · below corpus mean (-26.3 pp)
- MALF 95.9% corpus 64.8% · above corpus mean (+31.1 pp)
Lead product-problem code Computer Software Problem is 28% of coded problems · Lead manufacturer MEDTRONIC, INC. accounts for 92% of manufacturer-tagged reports · Top event location is 81% of location-tagged rows .
Analyzer, Pacemaker Generator Function in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Prosthesis
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
3,885 reports
- Collector
Collector, Urine, Powered, Non Indwelling Catheter
3,860 reports
- Analyzer (this)
Analyzer, Pacemaker Generator Function
3,843 reports
- Covid-19 Mult…
Covid-19 Multi-Analyte Antigen Device
3,840 reports
- Visual
Visual, Pregnancy Hcg, Prescription Use
3,833 reports
- System
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
3,810 reports
What this shows Analyzer, Pacemaker Generator Function carries 3,843 MAUDE reports, ranked #360 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 1,193 in 2025, up from an average of 646 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Analyzer, Pacemaker Generator Function
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Analyzer, Pacemaker Generator Function: 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 (3,843 here).
Similar death-typed counts
Nearest other device types by death-typed report count (3 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Analyzer, Pacemaker Generator Function 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 Analyzer, Pacemaker Generator Function; 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.