Model Number 6662 |
Device Problem
Device Inoperable (1663)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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Sjm 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.Sjm defers to the patient's physician regarding medical history.
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Event Description
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The patient reports after undergoing a surgical procedure on (b)(6) 2017, the ipg was unable to communicate with the patient controller.The sjm representative was unable to resolve the issue.It was determined the ipg was inoperable.The patient underwent surgical intervention on (b)(6) 2017 where the ipg was removed and replaced.
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Event Description
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Follow up information identiified the issue was resolved.
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Manufacturer Narrative
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The capa was initiated on 2016-02-23 to address the issue of the proclaim ipg entering service application (orion ipg family).Investigation is complete and being monitored by the manufacturer.
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Search Alerts/Recalls
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