Boston Scientific Neuromodulation Corporation PSC5210W ユーザーズマニュアル

Safety Information

15

Adverse Effects
Potential risks are involved with any surgery. The possible risks of 
implanting a pulse generator as part of a system to deliver spinal cord 
stimulation include:

• Lead migration, resulting in undesirable changes in stimulation 

and subsequent reduction in pain relief.

• System failure, which can occur at any time due to random fail-

ure(s) of the components or the battery. These events, which may 
include device failure, lead breakage, hardware malfunctions, 

loose connections, electrical shorts or open circuits and lead insu-

lation breaches, can result in ineffective pain control.

• Tissue reaction to implanted materials can occur.
• Skin erosion at the IPG site can occur over time.
• Possible surgical procedural risks are: temporary pain at the 

implant site, infection, cerebrospinal fluid (CSF) leakage and, 

although rare, epidural hemorrhage, seroma, hematoma and 

paralysis.

• External sources of electromagnetic interference may cause the 

device to malfunction and affect stimulation.

• Exposure to MRI can result in heating of tissue, image artifacts, 

induced voltages in the neurostimulator and/or leads, lead dis-
lodgement.

• Undesirable stimulation may occur over time due to cellular 

changes in tissue around the electrodes, changes in electrode 

position, loose electrical connections and/or lead failure.

• The patient may experience painful electrical stimulation of the 

chest wall as a result of stimulation of certain nerve roots several 
weeks after surgery.

• Over time, the Stimulator may move from its original position.
• Weakness, clumsiness, numbness or pain below the level of 

implantation.

• Persistent pain at the IPG or lead site.

In any event, instruct the patient to contact their physician to inform 
him/her.