Model Number 3788 |
Device Problems
Self-Activation or Keying (1557); Device Stops Intermittently (1599)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 03/23/2015 |
Event Type
Injury
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Event Description
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It was reported the patient's ipg has been turning on and off by itself.Troubleshooting attempts to provide resolution have been unsuccessful.As a result, the patient plans to undergo surgical intervention on a later date.
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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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Event Description
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Follow-up revealed the patient's ipg was explanted and replaced.
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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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