Model Number 3688 |
Device Problem
Self-Activation or Keying (1557)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/07/2015 |
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.(b)(4).
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Event Description
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It was reported the patient's ipg turned on by itself.As a result, the patient's scs system was explanted.Prior to explant, the patient experienced pain at the ipg site (reported under mfr.Report#: 1627487-2015-08432).
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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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