Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 12/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/ method and conclusion codes along with investigation results will be provided in the final report.Date of event and concomitant medical products therapy dates are estimated.
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Event Description
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Related manufacturer reference numbers: 3006705815-2020-33466, 3006705815-2020-33467 and 1627487-2020-49280.It was reported the anchors had eroded and an infection was present at the anchor and leads.Devices were explanted.
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Event Description
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Related manufacturer reference number: 3006705815-2020-33466, 3006705815-2020-33467 and 1627487-2020-49280.Additional information received revealed the infection was treated with antibiotics to provide resolution.
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Manufacturer Narrative
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The reported issue for infection cannot be confirmed through product analysis testing.As received, the swift lock anchor showed no anomaly and worked as design.No root cause was identified for reported event.
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Search Alerts/Recalls
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