Model Number NEU_INS_STIMULATOR |
Device Problems
Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)
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Event Date 04/15/2016 |
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 health care provider (hcp) of a clinical study via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for parkinson's disease.It was reported that there was dysfunction of the ins with sudden stop and aggravation of parkinson's symptoms, occurring on both sides and on several occasions leading to a change of the ins with complete resolution afterwards.It was noted the patient had bilateral dbs.No further complications were reported as a result of this event.
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Manufacturer Narrative
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Country and initial reporter information updated as event occurred in (b)(6).Initial reporter fax: (b)(6).Initial reporter phone: (b)(6).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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Event Description
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The event was completely resolved on (b)(6) 2016.
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Search Alerts/Recalls
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