Model Number 97714 |
Device Problems
Energy Output Problem (1431); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 a manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation - failed back surgery syndrome/spinal pain.It was reported that the stimulation output changed unexpectedly.The manufacturer's representative (rep) was told by the patient that the patient's as settings were ramping up unexpectedly when using as.Rep was unable to see patient today so wanted patient to turn off as until patient can be seen by the rep to do troubleshooting.Rep noted that the patient had routine reprogramming last week with the rep.No further complications were reported/anticipated.
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Manufacturer Narrative
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Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.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 from the reps best determination th e cause was the transition zone with the battery; it wasn't picking up her redine and was too strong.
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Manufacturer Narrative
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Patient weight updated.If information is provided in the future, a supplemental report will be issued.
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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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