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 12/12/2014 |
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 charger.It was also reported the patient has not charged her ipg in approximately 2 months and the patient's programmer reflects a communication error.Follow-up information revealed 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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Event Description
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Follow-up information revealed the patient's ipg was explanted and replaced.Therapy was reportedly restored postoperative.
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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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