Model Number 3788 |
Device Problems
Failure to Charge (1085); No Device Output (1435)
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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.
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Event Description
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It was reported the patient's ipg is tilted 90 degrees in the pocket.As a result the patient was unable to charge and has not had stimulation for "months and months." surgical intervention is planned to address the issue.
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Event Description
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It was reported the patient's ipg was explanted and replaced with a different model which resolved the issue.
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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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