Model Number 97712 |
Device Problems
Energy Output To Patient Tissue Incorrect (1209); Energy Output Problem (1431); Device Operates Differently Than Expected (2913); Insufficient Information (3190)
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Patient Problems
Pain (1994); Therapeutic Effects, Unexpected (2099)
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Event Date 12/12/2017 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a patent regarding their neurostimulator (ins) that was implanted for spinal pain.It was reported that patient feels stimulation all the time even when off/on.Patient was not sure if it working or not.Patient still has sensation when on/off.Patient was in the hospital some time ago and had an mri and knew stim was off.On (b)(6) 2018 patient had pain in back, hips, ankles and feet and been having pain there for some time.That was also the day it was the worst yet.Patient has had pain around implant site since implant.Patient mentioned other surgeries which were before implant and not related.Patient stated that the pain started a while ago, a year or two; an exact date was not provided.A manufacturer rep later stated that they contacted the patient and will be seeing them.No further complications were reported/anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a manufacturer¿s representative (rep).The rep reported that the cause of the patient feeling stimulation sensation all the time when on/off was determined to be user error.The patient had confusion regarding stimulation and working the programmer correctly to turn her stimulator (ins) on/off.The rep reported that the pain in her back, hips, ankles and feet were all pre-existing prior to the ins implant.The rep reported that the patient was reprogrammed in the office on (b)(6) 2018 to adjust her ins settings in order to achieve optimal settings to help reduce her painful areas.The issues were resolved.No further complications were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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