Model Number 3788 |
Device Problems
Failure to Charge (1085); Nonstandard Device (1420); No Device Output (1435); Use of Device Problem (1670)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 03/06/2015 |
Event Type
Injury
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Event Description
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It was reported the patient stopped using and recharging her scs system because she was no longer experiencing pain, and as a result, the ipg became inoperable.The patient then developed new pain and wanted to use her scs system.The patient underwent surgical intervention to remove and replace her ipg.
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Event Description
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Follow up information has identified the patient's new scs system is working well and the patient is satisfied.
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Manufacturer Narrative
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This ipg serial number was included in a field advisory (b)(4).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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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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Search Alerts/Recalls
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