Model Number 459888 |
Device Problem
Device Contamination with Body Fluid (2317)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/21/2017 |
Event Type
malfunction
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Event Description
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It was reported that during the implant procedure, blood ingressed into the body of the left ventricular (lv) lead after placement.It was noted there was blood visible from the lead tip and back up into the lead body.The lv lead was removed and replaced.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the full lead was returned and analyzed.Analysis was performed and no anomalies were found.The analyst noted that by design, left heart leads are manufactured with a septum in the tip that will sometimes allow blood ingress.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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