Model Number 37711 |
Device Problems
Device Displays Incorrect Message (2591); Charging Problem (2892)
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Patient Problems
Edema (1820); Swelling (2091); Ambulation Difficulties (2544)
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Event Date 05/01/2017 |
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 had been implanted with a neurostimulator(ins) for post lumbar laminectomy syndrome, lumbar radiculopathy, and spinal pain.It was reported that the patient was unable to charge either of their devices for the past three weeks.The ins recharger showed "discharged" a screen.The patient was instructed to press the green button when they saw that message, and the ins recharger showed a charging screen.It was reviewed that the patient would need to charge both inss to a quarter then turn stimulation back on.The patient also reported trouble with their legs, they were having edema really badly.No further complications were 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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Event Description
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Additional information received from the consumer reported that they have edema to both legs up to their neck and it limited the activities they could do as their mobility was very shaky.The edema had not been resolved and they were having another round of swelling.The patient stated this time was the worst from their toes up their legs.
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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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