![]() ![]() “Abbott is committed to providing the highest quality products and support,” the company’s letter concluded. Meanwhile, they should be careful not to alter their own connections with their patients’ IPGs-via the Clinician Programmer app-by maintaining Bluetooth pairings and disabling any automatic software updates that may take place while a device is in MRI mode. They should also ensure that patients have updated the app’s software to its latest version before entering the scan-safe mode. The devicemaker recommended that physicians also remind their patients not to break the Bluetooth connection, nor to alter, damage or lose the Patient Controller while the device is in MRI mode. Since receiving the complaints, Abbott has not only updated the devices’ instructions for use but also added a note to the Patient Controller app’s screen while it’s in MRI mode to remind patients not to delete the Bluetooth pairing between the app and implant. However, it noted in the letter that the issue’s incidence rate was hovering around 0.06% of all of the devices distributed around the world, about half of which required additional surgeries to correct. In those cases, surgery will be needed to remove the old IPG and implant one that can be connected anew to a Patient Controller.Ībbott didn’t disclose the exact number of complaints it’s received related to the issue, nor whether any associated injuries or patient deaths have occurred. If a user isn’t able to access the Patient Controller that was previously paired with their IPG, they won’t be able to exit MRI mode, therefore preventing their neuromodulation therapy from resuming. The company attributed the lost connections to instances where a user deleted the Bluetooth pairing between the app and IPG, lost or disabled the app or upgraded the iOS software on the Apple device while the IPG was in MRI mode. ![]() These incidents occurred when the implantable pulse generator (IPG) had lost communication with the Patient Controller app, which is installed on either a user’s own Apple device or one provided by Abbott. The device, which does not need to be recharged, is indicated for the treatment of chronic back pain.According to a letter (PDF) Abbott sent to healthcare provider customers in July, some users submitted complaints describing how they’d been unable to resume neuromodulation therapy after a stint in MRI mode. Jude Medical-now a division of Abbott- snagged a full-body MRI label from the FDA for its Elite Spinal Cord Stimulation System. MRI-compatibility makes such devices an option for patients with chronic pain who were previously ineligible because they might need diagnostic imaging in the future. ![]() Neurostimulation is an alternative treatment to opioids and invasive surgery for patients with chronic pain. Stimwave also markets the Freedom Spinal Cord Stimulation (SCS) system, which is placed near the spinal cord to relieve chronic low back and leg pain. RELATED: Startup gains FDA clearance for first tiny, injectable neuromodulation system for back pain Konstantin Slavin, a professor of neurosurgery at University of Illinois at Chicago, in the statement. "This is great news for many chronic pain patients who previously did not have a minimally-invasive implant option available for peripheral nerve-related pain and will continue to require frequent MRI scans throughout their body for management of their pain and monitoring of their current and future medical needs,” said Dr.
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