Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 09/24/2018 |
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 2 of 2 reference mfr.Report#: 3006705815-2018-02387.It was reported that the patient was experiencing unintended stimulation.As a result, the patient may undergo surgical intervention at a later date.
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Event Description
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Device 2 of 2 reference mfr.Report#: 3006705815-2018-02387.Follow up revealed that the patient's leads were explanted and replaced through surgical intervention.Therapy was restored post-op.
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Search Alerts/Recalls
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