Model Number 3771 |
Device Problem
Charging Problem (2892)
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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).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 programmer reflected an "ipg battery low" warning even though the ipg was charged.It was noted a spare charger also reflected the same warning.In addition, the patient's charger had never indicated a full charge since the patient was implanted.A replacement charger was sent to the patient which did not resolve the issue.Followup information revealed the patient underwent surgical intervention where the ipg was explanted and replaced.The patient reported effective therapy postoperative.The event date is unknown.
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Event Description
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Follow-up information revealed the patient is doing well postoperative.Surgical intervention resolved the reported issue.
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Search Alerts/Recalls
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