Model Number 6788 |
Device Problem
Device Stops Intermittently (1599)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 10/03/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).This device is not approved for sale in the usa, but is similar to a usa marketed/approved device.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 ((b)(6)) experienced the ipg shutdown unexpectedly.Consequently, the patient experienced immediate return of her symptoms.The physician decided to explant and replace the patient's dbs ipg.
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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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