Model Number 97714 |
Device Problem
Energy Output Problem (1431)
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Patient Problems
Dizziness (2194); Ambulation Difficulties (2544)
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Event Date 07/01/2018 |
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 the manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation - spinal pain.It was reported that the patient was light-headed and off balance.The manufacturer's representative (rep) met with the patient today to check stimulator after patient reported of feeling light-headed.Light headed was usually in the morning but was sporadic throughout the day.Patient did monitor blood pressure but caller could not confirm if he was on medication and did not think he was.Patient called their healthcare provider and was told to see his family practice doctor and did give patient a clean bill of health.Patient was programmed sub-threshold in an ld configuration.The rep suggested the patient to turn stim off for several days to see if this issue changes.It was reported this was a sudden change in therapy/symptoms.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 the manufacturer's representative.It was reported that cause was not determined.No actions were taken to resolve the issue.
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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 the manufacturer's representative.It was reported the patient had an mri and ct scan, the mri showed a spinal compression issue where the lead was.The patient is being seen on thursday by an hcp.Patient wants to keep system because it helps him.
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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 the manufacturer's representative.It was reported that the hcp did not think the lead was causing the compression.The hcp stated they might decompress via laminotomy the are because it might be too narrow in the area the lead was.The potential surgery was not scheduled yet as far as the rep knew.
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Search Alerts/Recalls
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