Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 1 of 2.Reference mfr.Report#: 1627487-2018-01502.It was reported the patient has been receiving inadequate coverage and therapy in an unintended area due to both of their leads migrating.Reprogramming attempts have been unable to provide needed therapy.As a result, the patient may undergo surgical intervention on a later date.The patient has proposed injections and medicine changes for the meantime.
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Event Description
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Device 1 of 2.Reference mfr.Report#: 1627487-2018-01502.Follow-up revealed the patient's leads were explanted and replaced.Surgical intervention addressed the patient's issue.
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Search Alerts/Recalls
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