Model Number 3788 |
Device Problems
No Device Output (1435); Charging Problem (2892); Communication or Transmission Problem (2896)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 09/03/2015 |
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 is unable to establish communication between his ipg and external devices.Subsequently, the patient will undergo surgical intervention as the next course of action.
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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 sjm representative met with the patient and determined the patient's ipg is inoperable.In addition, it was reported the patient had not recharged the device in over a year.
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Event Description
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Additional review of the manufacturer's device database indicated the patient's ipg was previously explanted and replaced on (b)(6) 2015.
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Search Alerts/Recalls
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