ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS TRIAL LEAD
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Model Number 3086 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 08/29/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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It was reported that infection was discovered on the lead sites.As a result, the patient was treated with oral antibiotics.Reportedly, the infection has resolved.
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Manufacturer Narrative
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An event of infection was reported to abbott.It was conveyed that the infection originates at the lead site(s).The patient was treated with antibiotics and the infection has reportedly cleared.As a result, a device history record was performed to review and confirm the sterility of the lead(s).Based on the documents reviewed, the source of the infection is yet to be substantiated.
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Search Alerts/Recalls
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