Pulse Generator, Permanent, Implantable
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, Permanent, Implantable MID-BOOK · MAUDE
#39 of 1000 · 92,723 reports · 1997–2026
- BOOK 92,723 reports
- RANK #39 of 1000
- DEATH 3,860 death-typed
- INJ 48,343 injury-typed
- MALF 40,319 malfunction
- SPAN 1997–2026
- PEAK 2021: 8,538
- PHOTO Bed
Nearest event-volume peer: Bed, Ac-Powered Adjustable Hospital (334 report gap)
Pulse Generator, Permanent, Implantable sits #39 of 1000 among tracked device types with 92,723 MAUDE reports spanning 1997–2026. 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 4.2% corpus 1.5% · above corpus mean (+2.6 pp)
- INJ 52.1% corpus 30.4% · above corpus mean (+21.7 pp)
- MALF 43.5% corpus 64.5% · below corpus mean (-21.0 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 24% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC.(CRM-SYLMAR) accounts for 21% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .
Pulse Generator, Permanent, Implantable in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Pulse Generat… (this)
Pulse Generator, Permanent, Implantable
92,723 reports
- Bed
Bed, Ac-Powered Adjustable Hospital
92,389 reports
- System
System, X-Ray, Fluoroscopic, Image-Intensified
90,588 reports
- Prosthesis
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
87,564 reports
- Laparoscope
Laparoscope, General & Plastic Surgery
80,330 reports
- Stimulator
Stimulator, Electrical, Implantable, For Incontinence
79,738 reports
What this shows Pulse Generator, Permanent, Implantable carries 92,723 MAUDE reports, ranked #39 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, Permanent, Implantable
Top Manufacturers
Event Locations
Compare ST. JUDE MEDICAL, INC.(CRM-SYLMAR) vs MEDTRONIC PUERTO RICO OPERATIONS CO. →
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Pulse Generator, Permanent, Implantable, 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 (92,723 here).
Similar death-typed counts
Nearest other device types by death-typed report count (3,860 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Pulse Generator, Permanent, Implantable 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, Permanent, Implantable; 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.