![]() MRI scans may result in excessive heating of the lead electrodes and serious patient injury. Do not perform an MRI scan on patients who have multiple MR Conditional neurostimulation systems for pain (multiple IPGs for pain). Do not perform an MRI scan on patients who have an external neurostimulation trial system or any components that are not fully implanted. The MRI scan may result in excessive heating of the system and serious patient injury. Do not perform an MRI scan on patients who have any portion of their implanted system exposed due to skin erosion. This can be confirmed with X-ray imaging of the neck, head, and extremity regions or by referring to the patient records. Head or extremity MRI scans can be conducted safely using a Detachable Head or Extremity RF transmit-receive coil when no parts of the implanted neurostimulation system are within the transmit-receive coil according to the conditions specified for each system in the MRI labeling. MRI scans of implants that are not located in approved locations can possibly result in increased unintended stimulation, excessive heating at the lead electrodes, and serious patient injury. Lead tips can be located at different spinal epidural levels. Two leads should travel in close proximity to one another from the IPG to the spine. The MR Conditional leads must be implanted in the epidural space and routed subcutaneously to the IPG pocket. Location of implanted system. To meet the MR Conditional requirements, components must be implanted according to the approved locations specified by the MRI labeling. MRI scans of nonfunctional leads may result in excessive heating occurring at the location of the implanted lead electrodes and serious patient injury. There may be a problem with the implanted lead(s).” message displays when attempting to enter MRI mode on the patient controller. Do not perform an MRI scan on patients when the “MRI is Not Advised. Do not perform an MRI scan on patients who have an incomplete neurostimulation system, where a lead is present without the IPG or disconnected from the system. Serious patient injury could occur.Ībandoned devices. ![]() Do not perform an MRI scan on patients who have any components of a neurostimulation system that are unapproved for use in an MR environment. The following warnings, precautions, and potential adverse events apply when performing MRI scans on Abbott MR Conditional SCS/DRG systems. NOTE: Lead tip must be located between C6 and S2 Upper buttock, low back, flank, or abdomen NOTE: Lead tip must be located between T7 and T12 NOTE: Lead tip must be located between C1 and S2 Refer to product manuals for complete indications, contraindications, warnings, precautions and potential adverse events.Upper buttock, low back, midline, flank or abdomen Adverse events may result in fluctuations in blood glucose in patients with diabetes. May include: undesirable change in stimulation (uncomfortable, jolting or shocking) hematoma, epidural hemorrhage, paralysis, seroma, infection, erosion, device malfunction or migration, pain at implant site, loss of pain relief, and other surgical risks. Recharging a rechargeable neurostimulator may result in skin irritation or redness near the implant site. Avoid activities that put stress on the implanted neurostimulation system components. Safety and effectiveness has not been established for pediatric use, pregnancy, unborn fetus, or delivery. A preoperative assessment is advised for some patients with diabetes to confirm they are appropriate candidates for surgery. Patients with diabetes may have more frequent and severe complications with surgery. An implanted cardiac device (e.g., pacemaker, defibrillator) may damage a neurostimulator, and electrical pulses from the neurostimulator may cause inappropriate response of the cardiac device. ![]() Sources of electromagnetic interference (e.g., defibrillation, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact with the system, resulting in unexpected changes in stimulation, serious patient injury or death. Spinal cord stimulation (SCS) is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.ĭiathermy - Energy from diathermy can be transferred through the implanted system and cause tissue damage resulting in severe injury or death. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |