Model Number 3788 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 12/16/2014 |
Event Type
Injury
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Event Description
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Device 1 of 2.Reference mfr report#1627487-2015-08016.The patient received two extensions with the same lot number.It was reported stimulation is not effective and all programs are auto-reducing.X-rays revealed the extensions had pulled out the header of the ipg.Surgical intervention was undertaken on (b)(6) 2014 explanting and replacing the ipg and extensions which resolved the issue.
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Event Description
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Device 1 of 2.Reference mfr report#1627487-2015-08016.
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Manufacturer Narrative
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Udi(di) (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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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#1627487-2014-08016.
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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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