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 2 of 2.Reference mfr report #1627487-2015-12035.
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Event Description
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Device 2 of 2.Reference mfr report #1627487-2015-12034.
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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 any anomaly that could have 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 2 of 2.Reference mfr report #1627487-2015-12034.
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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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Search Alerts/Recalls
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