Model Number 97714 |
Device Problems
Unintended Collision (1429); Device Operates Differently Than Expected (2913)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 04/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 for spinal pain.It was reported that there was a change in therapy.The patient was getting into the car and had fallen right on his back.The family member/friend of the patient had the patient programmer and turned the stimulator on after the fall and everything was okay and everything was good.An ambulance came; however the patient didn¿t want to go to the hospital.The patient had just gone to the pain specialist on (b)(6) 2017 to get the device readjusted.It was reviewed that the only way to tell if the device was alright was to have the health care provider check the device.No further complications were reported or anticipated.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 consumer reporting that the patient fell and twisted their knee on the (b)(6) and went to the emergency room on the (b)(6).The caller also asked about mri compatibility guidelines for a procedure unrelated to the device or therapy.No further patient complications have been reported as a result of this event.
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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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