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 06/19/2018 |
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: 1627487-2018-06427.It was reported the patient experienced bladder discomfort only while tonic stimulation is turned on.As a result, the patient may be awaiting surgical intervention.
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Event Description
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Device 2 of 2: reference mfr.Report: 1627487-2018-06427.Follow up information identified the physician opted to electively replace the patient¿s ipg for access to burst therapy on (b)(6) 2018.No surgical intervention was undertaken on the leads.
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Search Alerts/Recalls
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