FDA DeviceClass INotable
FDA Recall: INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM
Description
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.
Hazard
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.
Remedy
1079
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