Model Number 37712 |
Device Problems
Energy Output Problem (1431); Vibration (1674); Data Problem (3196); Noise, Audible (3273)
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Patient Problems
Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/26/2018 |
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 with an implantable neurostimulator (ins) for an unknown indication for use.It was reported that the patient was having a minor issue with their stimulator, they thought they were hearing a buzzing noise from the stimulator and it automatically bumped up on its own.The patient stated that they lowered stimulation and discussed this with the healthcare provider (hcp).Their hcp told them to call the manufacturer and to meet with a manufacturer representative (rep) to have their device checked and for reprogramming.The reps role was reviewed and the patient then stated that their hcp does not reach out and tells them to reach out.Patient services sent an email out to the local reps on the patient¿s behalf.No symptoms were reported.The event began about two weeks ago in 2018.No further complications were reported/anticipated.
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Manufacturer Narrative
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Correction: adverse event and product problem should be selected.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Device code (b)(4) no longer applies.Patient code (b)(4) no longer applies.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 patient clarifying that the stimulator was not making a buzzing noise but rather they were experiencing a buzzing sensation.Actions taken to resolve the buzzing sensation was the patient changed the settings to a high intensity setting.The cause of the stimulation settings increasing on their own was not determined.Actions taken to resolve the settings increasing on their own were not reported.The patient also did not report whether their issues were resolved.Their weight at the time of the event was asked but not reported.No further complications were reported/anticipated.
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Search Alerts/Recalls
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