Model Number 3716 |
Device Problem
Device Inoperable (1663)
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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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It was reported the patient's ipg stopped working due to an auto accident.As a result, the patient's ipg was explanted and replaced on (b)(6) 2015.The issue was resolved by surgical intervention.
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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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