Model Number 3660 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 12/21/2015 |
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.
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Event Description
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It was reported the patient's scs ipg would not pair with the clinician programmer.The programmer(s) would only display an error message when attempting to pair with the ipg.The patient's scs ipg was explanted and replaced which resolved the issue.
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Manufacturer Narrative
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A capa investigation was initiated on 2016-02-23 to investigate the issue in which the ipg experienced loss of power, causing the patient to lose pain relief requiring replacement of the device.Investigation is currently in progress.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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