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 06/01/2015 |
Event Type
Injury
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Event Description
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It was reported the patient is unable to establish communication between her ipg and external devices.It was also reported the patient's ipg is inoperable.Follow-up information revealed the patient was last able to successfully recharge her ipg approximately 6 months ago.The patient stated she was in the hospital for unrelated reasons and was unable the recharge her scs system.The patient will undergo surgical intervention as the next course of action.
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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.Reportedly, the patient has effective stimulation coverage postoperative.
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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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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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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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