Model Number 37603 |
Device Problem
Energy Output Problem (1431)
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Patient Problems
Fall (1848); Incontinence (1928); Complaint, Ill-Defined (2331); Dyskinesia (2363); Ambulation Difficulties (2544); Cognitive Changes (2551)
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Event Date 06/19/2019 |
Event Type
Injury
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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 who was implanted with an implantable neurostimulator (ins) for parkinson's dual and dbs therapy indications.It was reported it was no more than one day after the implant the patient started having all kinds of problems with hallucinations and things associated with dementia or alzheimer's.The caller was wondering if there was a way to check the lead.It was confirmed the therapy was on.This was considered a sudden change in symptoms/therapy.The patient was to follow up with the healthcare provider (hcp).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 manufacturer¿s representative (rep) reported they received a call from the healthcare provider (hcp) asking if there was a wide spread issue with patient¿s hallucinating with implantable neurostimulator (ins) replacement.It was reviewed with the rep.There was generally no hallucinations with just ins replacement, unless there were programming changes and there was no widespread issue with hallucinations.The rep.Was scheduled to meet with the patient on august 12th to check the system¿s integrity.No further complications were 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 a consumer via a manufacturer representative (rep) reiterating that ever since she had a battery change their parkinson's symptoms have been worse.Having hallucinations unable to walk and incontinent.No diagnostics/troubleshooting performed.No interventions/actions taken.The issue is not yet resolved.
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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 a manufacturing representative (rep) indicated they were inquiring if there was copper in the dbs implant.It was reviewed that there was no copper that was in contact with the patient, and any copper in circuitry is inside the hermetically sealed ins.The healthcare provider (hcp) indicated today they wanted to do a blood test for copper as the patient had increased dyskinesia, but it had been reduced since reprogramming by the hcp.The patient was still having balance issues, falling, and other issues previously reported.
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Search Alerts/Recalls
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