AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Publicado el 4 de septiembre de 2019 · Inicio del retiro: 16 de abril de 2019
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial device testing subsequent to implantation it was identified that two of the devices that were labeled as 8 contact depth electrodes (SD08R-SP05X-000) were in fact 6 contact depth electrodes (SD06R-SP05X-000) . There was no impact to the patient due to this incident.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Ad-Tech Medical Instrument Corporation
- Distribuidor
- Worldwide - Nationwide distribution in the state of Illinois and countries of Russia and United Kingdom
- Lote
- Catalog Numbers SD08R-SP05X-000 SD06R-SP05X-000 LOT NUMBERS 127219 208140699 127357 208140699
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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