Model Number 3788 |
Device Problems
Failure to Charge (1085); No Device Output (1435); Use of Device Problem (1670)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 01/01/2015 |
Event Type
Injury
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Event Description
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It was reported the patient has not charged her scs system in approximately 6 months as the patient lost her charger.A back-up charger was also used without success.It was also reported the patient was unable to establish communication between her ipg and patient programmer.The patient will undergo surgical intervention as the next course of action.
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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 information revealed the patient underwent surgical intervention on (b)(6) 2015, where the ipg was explanted and replaced.The patient reported effective stimulation coverage postoperative.
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Search Alerts/Recalls
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