International safety notice
Sistemas Proclaim XR SCS y Proclaim Elite SCS, modelos 3660 y 3662; Sistema de neuroestimulación Proclaim DRG, modelo 3664; Sistema Infinity DBS, modelos 6660 y 6662
Spain / AEMPS · ESP · Aug 18, 2023
Key facts
| Title | Sistemas Proclaim XR SCS y Proclaim Elite SCS, modelos 3660 y 3662; Sistema de neuroestimulación Proclaim DRG, modelo 3664; Sistema Infinity DBS, modelos 6660 y 6662 |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | Sistemas Proclaim XR SCS y Proclaim Elite SCS, modelos 3660 y 3662; Sistema de neuroestimulación Proclaim DRG, modelo 3664; Sistema Infinity DBS, modelos 6660 y 6662 |
| Manufacturer | Abbott Neuromodulation, EEUU. |
| Models | 2023-379, 05415067030023, 05415067031426, 05415067031419, 91.822.52.89, 05415067020222SISTEMA, 05415067030016, 05415067020215SISTEMA, 28022, 05415067020192, 05415067020215, 3662.UDI and 4 more |
| Event type | Safety Notice |
| Date | Aug 18, 2023 |
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