Model Number 3189 |
Device Problem
Malposition of Device (2616)
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Patient Problem
Discomfort (2330)
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Event Date 12/19/2014 |
Event Type
Injury
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Event Description
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Device 1 of 2.Reference mfr report # 1627487-2015-12035.It was reported the patient's were explanted and replaced with different model leads.The physician elected to explant and replace the ipg with a different model.Note there were not complaints or issues with the ipg.The system was programmed and the patient reportedly receives effective stimulation therapy.
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Event Description
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Device 1 of 2.Reference mfr report #1627487-2015-12035.
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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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Manufacturer Narrative
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Results : the complaint could not be confirmed for ¿discomfort¿ at the lead site.The visual inspection of returned leads did not find anomaly that could contributed to the pain.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 #1627487-2015-12035.It was reported the patient has discomfort at the lead site due to the lead pressing against the skin at the insertion site (occipital placement, off-label use).Images taken confirmed the leads migrated and the physician is concerned about erosion.Surgical intervention is planned to address the issue.
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Manufacturer Narrative
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(b)(4).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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Search Alerts/Recalls
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