Model Number 3183 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Skin Erosion (2075)
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Event Type
Injury
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Event Description
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Device 1 of 2.Reference mfr.Report#: 1627487-2015-05005.It was reported the patient's scs system was explanted due to one of the leads eroding through the patient's skin and an infection at the lead site.The date of explant remains unknown.
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Manufacturer Narrative
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Method: the device history and sterilization records were reviewed.Results: the device history and sterilization records reviewed were found to meet specifications and no anomalies were found.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.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#: 1627487-2015-05005.Follow-up revealed the patient's scs system was explanted and replaced with a competitor's device on 08/31/2011.Verification via follow-up revealed the infection that was initially reported was related to a competitor's device.
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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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