Product id 97714, lot#, serial# (b)(4), implanted: 2016 (b)(6), explanted, product type implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
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Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient reported to clinic with issues after an mri.Patient stated she felt burning/stabbing shortly after mri started, and it had to be aborted.The patient reported painful zap/burn mid back and upwards to neck.The tech reported running 1.5 and sar at 2 watts/kg.The patient was confirmed to be implanted with mri safe systems.The tech reported using mri guides for patient's specific device.The tech also stated that the patient has had similar mris in the past with them using the same criteria.Troubleshooting/diagnostics were performed.Impedances were tested and performing within range.The devices were determined to be fine and in service.The issue was resolved at the time of the report.Refer to manufacturer report # 3004209178-2021-06149.
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