Model Number 97702 |
Device Problems
Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211); Unintended Collision (1429)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 06/01/2018 |
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 consumer regarding a patient who was implanted with a neurostimulator (ins) for spinal pain.It was reported that six or seven days ago, the patient fell on their back while on vacation and the pain was not going away.The patient further stated that when they shut off the stimulator itself, they could still feel stimulation.The patient stated they could barely sit down and they had to sit down sideways to avoid a lot of the pain because sitting down was very painful.The patient programmer (pp) showed that the implant was on.The patient confirmed that they had just turned the stimulation back on a few minutes ago and that was why the pp showed the implant to be on.They reported they checked the implant at the time and the pp showed that the implant was off.The patient was redirected to follow up with a healthcare professional.No further complications were reported.Follow up was conducted.
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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 received from the patient on (b)(6) 2018.The patient stated that they fell on a rope and it got stuck under their feet.The patient clarified that the device was never off.No further complications were reported/are 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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Search Alerts/Recalls
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