Model Number 3788 |
Device Problem
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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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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The patient reported stimulation was lost approximately 4-6 months ago and the last successful recharge of the ipg was around that same time.Reportedly, communication could not be established between the charger and the ipg.Troubleshooting of the issue will be scheduled.Follow-up identified the ipg is inoperable.Surgical intervention may be undertaken 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 identified surgical intervention was undertaken on (b)(6) 2016 during which time the ipg was explanted and replaced with a new model which resolved the issue.
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Search Alerts/Recalls
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