Model Number 3788 |
Device Problems
Failure to Charge (1085); 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 05/27/2015 |
Event Type
Injury
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Event Description
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It was reported the patient failed to recharge the ipg.As a result, the device was deemed inoperable.Follow-up identified surgical intervention was undertaken on (b)(6) 2015 during which time the ipg was explanted and replaced with a non-rechargeable device.
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Manufacturer Narrative
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(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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