Product Info

10001045 REV B 23
• Failure or malfunction resulting in ineffective pain control or other undesirable changes in stimulation, and
possibly requiring trial lead removal
• Skin erosion or seroma at the lead site
• Pressure sores
• External sources of electromagnetic interference that cause the device to malfunction and could affect
stimulation
• Exposure to magnetic resonance imaging (MRI) can result in heating of tissue, image artifacts, induced
voltages in the leads, and lead dislodgement
• Infection
• Epidural mass formation around the lead
7.4 Risks Associated with External Device Components
• Tissue reaction or allergy to external materials
• Uncomfortable heating effects, discomfort or burn