Serious adverse events and stimulation-related adverse events reported by patients and centres
| Event . | SAE . | AE . |
|---|---|---|
| Surgical adverse events | ||
| Wound healing disorder | x | |
| Fracture of femur due to dystonic exacerbation one day after implantation | x | |
| Patient-related adverse events | ||
| Pneumonia two years after implantation resulting in deatha | x | |
| Dystonic storm (onset prior to DBS) resulting in death | x | |
| Subluxation of hip with necrosis of head of femur and chondrolysis necessitating hospitalization | x | |
| Viral infection with hospitalization | x | |
| Fall with consecutive worsening of symptoms and hospitalization | x | |
| Stimulation-related adverse events | ||
| Visual disturbance (reversible) | x | |
| Mild hyperkinesia (reversible) | x | |
| Paraesthesias (reversible) | x | |
| Worsening of gait and balance (reversible) | x | |
| Worsening of gait freezing (reversible) | x | |
| Blepharospasm under monopolar stimulation | x | |
| Device-related adverse events | ||
| Paraesthesias in the area of the generator implant | x | |
| Dislocation of pulse generator and cables necessitating surgical revisiona | x |
| Event . | SAE . | AE . |
|---|---|---|
| Surgical adverse events | ||
| Wound healing disorder | x | |
| Fracture of femur due to dystonic exacerbation one day after implantation | x | |
| Patient-related adverse events | ||
| Pneumonia two years after implantation resulting in deatha | x | |
| Dystonic storm (onset prior to DBS) resulting in death | x | |
| Subluxation of hip with necrosis of head of femur and chondrolysis necessitating hospitalization | x | |
| Viral infection with hospitalization | x | |
| Fall with consecutive worsening of symptoms and hospitalization | x | |
| Stimulation-related adverse events | ||
| Visual disturbance (reversible) | x | |
| Mild hyperkinesia (reversible) | x | |
| Paraesthesias (reversible) | x | |
| Worsening of gait and balance (reversible) | x | |
| Worsening of gait freezing (reversible) | x | |
| Blepharospasm under monopolar stimulation | x | |
| Device-related adverse events | ||
| Paraesthesias in the area of the generator implant | x | |
| Dislocation of pulse generator and cables necessitating surgical revisiona | x |
a: These events occurred outside the formal period of observation (preoperative to 15 months postoperatively).
Serious adverse events and stimulation-related adverse events reported by patients and centres
| Event . | SAE . | AE . |
|---|---|---|
| Surgical adverse events | ||
| Wound healing disorder | x | |
| Fracture of femur due to dystonic exacerbation one day after implantation | x | |
| Patient-related adverse events | ||
| Pneumonia two years after implantation resulting in deatha | x | |
| Dystonic storm (onset prior to DBS) resulting in death | x | |
| Subluxation of hip with necrosis of head of femur and chondrolysis necessitating hospitalization | x | |
| Viral infection with hospitalization | x | |
| Fall with consecutive worsening of symptoms and hospitalization | x | |
| Stimulation-related adverse events | ||
| Visual disturbance (reversible) | x | |
| Mild hyperkinesia (reversible) | x | |
| Paraesthesias (reversible) | x | |
| Worsening of gait and balance (reversible) | x | |
| Worsening of gait freezing (reversible) | x | |
| Blepharospasm under monopolar stimulation | x | |
| Device-related adverse events | ||
| Paraesthesias in the area of the generator implant | x | |
| Dislocation of pulse generator and cables necessitating surgical revisiona | x |
| Event . | SAE . | AE . |
|---|---|---|
| Surgical adverse events | ||
| Wound healing disorder | x | |
| Fracture of femur due to dystonic exacerbation one day after implantation | x | |
| Patient-related adverse events | ||
| Pneumonia two years after implantation resulting in deatha | x | |
| Dystonic storm (onset prior to DBS) resulting in death | x | |
| Subluxation of hip with necrosis of head of femur and chondrolysis necessitating hospitalization | x | |
| Viral infection with hospitalization | x | |
| Fall with consecutive worsening of symptoms and hospitalization | x | |
| Stimulation-related adverse events | ||
| Visual disturbance (reversible) | x | |
| Mild hyperkinesia (reversible) | x | |
| Paraesthesias (reversible) | x | |
| Worsening of gait and balance (reversible) | x | |
| Worsening of gait freezing (reversible) | x | |
| Blepharospasm under monopolar stimulation | x | |
| Device-related adverse events | ||
| Paraesthesias in the area of the generator implant | x | |
| Dislocation of pulse generator and cables necessitating surgical revisiona | x |
a: These events occurred outside the formal period of observation (preoperative to 15 months postoperatively).
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