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Table 3 Grading system developed for the severity of clinical complications resulting from implanted neural interface failure, including examples. This was modified from the Clavien-Dindo grading system for surgical complications

From: Overcoming failure: improving acceptance and success of implanted neural interfaces

Grade

Description

Examples

I

Minor loss of efficacy or complication requiring no surgical or pharmacological intervention

Reprogramming, warm compress for edema, imaging

II

Complications requiring pharmacological intervention

Antibiotics or steroids for infection or edema

 IIa

Single treatment

 

 IIb

Repeated treatment

 

III

Complications requiring outpatient surgical intervention

Draining a hematoma or debriding skin necrosis

IV

Temporary loss of function or disability

Rehabilitation for nerve compression

V

Complications requiring inpatient surgical intervention

Revision, removal, or replacement of part or all of device

 Va

Intervention not under general anesthesia

 

 Vb

Intervention under general anesthesia

 

VI

Permanent loss of function or disability

Ongoing rehabilitation for paralysis, treatment of seizures

VII

Life-threatening complications requiring intensive care management

Sepsis from infection

 VIIa

Single organ dysfunction

 

 VIIb

Multi-organ dysfunction

 

VIII

Death related to the complication

Sepsis from infection