Model Number 3788 |
Device Problems
Bent (1059); Device Stops Intermittently (1599); Communication or Transmission Problem (2896)
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Patient Problems
Pain (1994); Inadequate Pain Relief (2388)
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Event Type
Injury
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Event Description
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It was reported the patient bumped into the edge of a counter top (event date is unknown).Unfortunately, the impact was received at the ipg site.Since the event, the patient has been experiencing pain at the ipg site, intermittent stimulation, and issues with the external devices communicating successfully with the ipg.The patient also alleges the ipg as being "bent" to the touch.As a result, the patient will undergo surgical intervention.
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Event Description
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Follow-up revealed the patient's ipg was explanted and replaced.Surgical intervention resolved the patient's issue(s).
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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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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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