Model Number 3268 |
Device Problem
Impedance Problem (2950)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Type
Injury
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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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Device 1 of 2.Reference mfr report #: 1627487-2017-07958.It was reported that the patient was experiencing overstimulation at the ipg site.In turn, the patient's lead tested for invalid impedances.As a result, surgical intervention may be taken to address the issue.
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Event Description
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Device 1 of 3.Reference mfr report #: 1627487-2017-07958.Reference mfr report #: 1627487-2017-07960.Follow up revealed that the patient underwent surgical intervention wherein both leads and ipg were replaced.The patient is very happy post operatively.
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Search Alerts/Recalls
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