Model Number 3609 |
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.
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Event Description
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It was reported both of the patient's scs ipgs have been inoperable for approximately the past four years.As a result, surgical intervention is planned to replace the ipg.(reference mfr.Report #1627487-2015-06358).The device lot number, manufacture date, and expiration date are unknown at this time.
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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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Additional information received identified the patient's ipg was explanted and replaced during surgery on (b)(6) 2015.Effective therapy was reportedly restored postoperative.
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Search Alerts/Recalls
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