Model Number 459888 |
Device Problems
Connection Problem (2900); Device Operates Differently Than Expected (2913)
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Patient Problems
Occlusion (1984); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/01/2017 |
Event Type
Injury
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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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Event Description
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It was reported that the left ventricular lead was not functioning and that there was a "device/lead connection problem".The lead and device were explanted and replaced.The patient is a participant in the (b)(6) trial clinical study.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, analyzed, and no anomalies were found.The low voltage 4 conductor was extrinsically pulled/stretched.There was a connector pin observation.The outer insulation of the lead was extrinsically melted but not breached.The outer insulation of the lead was observed to have blood ingression.Visual analysis of the lead indicated apparent explant damage.The analyst noted there is blood in the connector pin.There is blood in the outer insulation at various areas of the lead.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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Event Description
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It was also reported that three months prior to the procedure to replace the lead, there was an attempt to place a new left ventricular lead, but the patient had venous occlusion and the lead could not be placed at that time.
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Search Alerts/Recalls
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