Model Number 3788 |
Device Problem
Moisture or Humidity Problem (2986)
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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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It was reported the patient is without stimulation.Reportedly, the ipg is not communicating with the external devices.The sjm representative met with the patient and the issue was confirmed.It is unknown when the patient last recharged the ipg.Surgical intervention may be undertaken as the next course of action to address the issue.
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Manufacturer Narrative
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(b)(4).This ipg serial number was included in field advisories: 1627487-05242011-002-r.1627487-07262012-002-r.1627487-12192011-003-r.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) 2015 at which time the ipg was explanted and replaced.Effective stimulation was achieved postoperatively.The issue is resolved.
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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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