Pulse-Generator, Pacemaker, External
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 §870.3600 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Pulse-Generator, Pacemaker, External MID-BOOK · MAUDE
#187 of 1000 · 13,014 reports · 1992–2026
- BOOK 13,014 reports
- RANK #187 of 1000
- DEATH 85 death-typed
- INJ 1,004 injury-typed
- MALF 11,857 malfunction
- SPAN 1992–2026
- PEAK 2011: 1,865
- PHOTO Filler
Nearest event-volume peer: Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction (26 report gap)
Pulse-Generator, Pacemaker, External sits #187 of 1000 among tracked device types with 13,014 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 run above the device-type norm
Pulse-Generator, Pacemaker, External carries 91.1% MALFUNCTION-coded reports, 26.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.7% corpus 1.5% · below corpus mean (-0.9 pp)
- INJ 7.7% corpus 30.3% · below corpus mean (-22.6 pp)
- MALF 91.1% corpus 64.8% · above corpus mean (+26.3 pp)
Lead product-problem code Connection Problem is 20% of coded problems · Lead manufacturer MEDTRONIC, INC. accounts for 38% of manufacturer-tagged reports · Top event location I is 39% of location-tagged rows .
Pulse-Generator, Pacemaker, External in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Bone Cement
Bone Cement
13,130 reports
- Filler
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
13,040 reports
- Pulse-Generat… (this)
Pulse-Generator, Pacemaker, External
13,014 reports
- Clamp
Clamp, Vascular
12,982 reports
- Electrode
Electrode, Ph, Stomach
12,853 reports
- Shoulder Pros…
Shoulder Prosthesis, Reverse Configuration
12,771 reports
What this shows Pulse-Generator, Pacemaker, External carries 13,014 MAUDE reports, ranked #187 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 (643) held close to the prior two-year average of 635.
Related Entities for Pulse-Generator, Pacemaker, External
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Pulse-Generator, Pacemaker, External: 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 (13,014 here).
Similar death-typed counts
Nearest other device types by death-typed report count (85 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Pulse-Generator, Pacemaker, External 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, Pacemaker, External; 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.