Model Number 3660 |
Device Problem
Device Inoperable (1663)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 04/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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The capa investigation was initiated on (b)(6) 2016 to address the issue of the proclaim ipg (orion ipg family).Investigation is complete and being monitored by the manufacturer.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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It was reported that the patient lost therapy following an unrelated surgery.As a result, the patient underwent surgical intervention to have their ipg replaced.Issue has been resolved.
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Event Description
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Additional information received indicated that prior to the ipg being replaced, the device was unable to communicate with external devices.Due to the inability of the ipg to communicate, it was explanted and replaced.
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Search Alerts/Recalls
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