Model Number 3788 |
Device Problems
No Device Output (1435); Device Displays Incorrect Message (2591)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported the patient was no longer able to establish communication between her scs ipg and external devices (2501 comm error on programmer)-sjm representative confirmed (date of event is unknown).As a result, the scs ipg was explanted and replaced with a different model.
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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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Additional information received identified the patient's scs ipg became inoperable as a result of the patient not charging.It was also reported stimulation was restored with the surgical intervention.
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Search Alerts/Recalls
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