Model Number 3383 |
Device Problem
Disconnection (1171)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 12/02/2016 |
Event Type
Injury
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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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Event Description
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Device 3 of 4.Reference report #1627487-2016-06590, #1627487-2016-06591, #3006705815-2016-00708.It was reported the patient lost effective stimulation.An sjm representative interrogated the system where some contacts had high impedances.An x-ray was taken and revealed the extensions had pulled out of the ipg.Surgical intervention may be taken to address the issue.
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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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Device 3 of 4.Reference report #1627487-2016-06590, #1627487-2016-06591, #3006705815-2016-00708.The patient had a consult with the physician.The next course of action is undetermined at this time.
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Search Alerts/Recalls
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