International safety notice
Marcapasos (TRC-P) y desfibriladores (TRC-D) para terapia de resincronización cardiaca (TRC): · TRC-P VALITUDE™ · TRC-P VISIONIST™ · TRC-D RESONATE™ · TRC-D MOMENTUM™ · TRC-D AUTOGEN™ · TRC-D INOGEN™ · TRC-D VIGILANT™ · TRC-D CHARISMA™ · TRC-D DYNAGEN™ ·
Spain / AEMPS · ESP · Feb 12, 2019
Key facts
| Title | Marcapasos (TRC-P) y desfibriladores (TRC-D) para terapia de resincronización cardiaca (TRC): · TRC-P VALITUDE™ · TRC-P VISIONIST™ · TRC-D RESONATE™ · TRC-D MOMENTUM™ · TRC-D AUTOGEN™ · TRC-D INOGEN™ · TRC-D VIGILANT™ · TRC-D CHARISMA™ · TRC-D DYNAGEN™ · |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | Marcapasos (TRC-P) y desfibriladores (TRC-D) para terapia de resincronización cardiaca (TRC): · TRC-P VALITUDE™ · TRC-P VISIONIST™ · TRC-D RESONATE™ · TRC-D MOMENTUM™ · TRC-D AUTOGEN™ · TRC-D INOGEN™ · TRC-D VIGILANT™ · TRC-D CHARISMA™ · TRC-D DYNAGEN™ · |
| Manufacturer | Cardiac Pacemaker Inc (Boston Scientific Corporation), EEUU |
| Models | V2.06, 42947, 2019-075, 92179817-FA, V4.07, 28042, MODELO2869, 2018-003, AFECTADOS1 |
| Event type | Safety Notice |
| Date | Feb 12, 2019 |
At a glance
- No Recall
- Yes Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1