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 Type
Injury
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Event Description
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Follow-up information revealed the patient underwent surgical intervention on (b)(6)2015, where his 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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Event Description
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It was reported, the patient is unable to establish communication between his ipg and external devices.It was also reported the patient has not charged the ipg in several months.The patient is without stimulation.Subsequently, the patient will undergo surgical intervention as the next course of action.The event date is unknown.
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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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Search Alerts/Recalls
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