Model Number 3788 |
Device Problem
Device Inoperable (1663)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 07/30/2015 |
Event Type
Injury
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Manufacturer Narrative
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This ipg serial number is included in a field advisory.(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 was explanted and replaced with a different model due to it being inoperable.
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Manufacturer Narrative
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This ipg serial number is included in field advisories.Correction number: 1627487-07262012-002-r.Further investigation revealed the complaint was for a different patient with the same initial and same model ipg.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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