Electrophysiology: Mapping Adverse Event Data
High-density intracardiac mapping and EP diagnostic catheter adverse event reports.
Total Reports
5,982
Devices Tracked
200
Reports (30d)
55
Active Signals
0
Devices in EP Mapping
| Device | Total Reports | Last 30d |
|---|---|---|
ACHIEVE™DRF | 1,232 | 5 |
PENTARAY NAVMTD | 595 | 15 |
| 434 | 5 | |
| 414 | 1 | |
| 342 | 2 | |
PENTARAY NAVMTD | 280 | 1 |
| 165 | 2 | |
DECANAVDRF | 142 | 6 |
OCTARAY Mapping CatheterMTD | 132 | 4 |
ACHIEVE™DRF | 97 | 0 |
DECANAVDRF | 93 | 0 |
INQUIRY STEERABLE DIAGNOSTIC CATHETERDRF | 79 | 0 |
Advisor™DRF | 73 | 0 |
OCTARAY Mapping CatheterMTD | 71 | 2 |
PENTARAY NAVMTD | 70 | 0 |
POLARMAP™DRF | 68 | 0 |
NaviStarDRF | 61 | 0 |
LASSO NAVDRF | 61 | 0 |
OCTARAY Mapping CatheterMTD | 58 | 1 |
LassoDRF | 55 | 0 |
Inquiry™DRF | 55 | 0 |
OCTARAY Mapping CatheterMTD | 51 | 0 |
OPTRELL Mapping Catheter with TRUEref TechnologyMTD | 48 | 4 |
Advisor™ HD Grid X, Sensor Enabled™MTD | 41 | 3 |
OPTRELLDRF | 40 | 0 |
1–25 of 200 devices
All EP Mapping device pages (7)
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Get Early AccessUnderstanding this data
What FDA MAUDE data does and does not tell you
How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.
How a safety signal is detected
What the "Active Signals" count above means and the methods that separate a real signal from noise.
Post-market surveillance: a practical guide
Where MAUDE fits in the wider regulatory picture and the data sources teams rely on.