Model Number 1458QL/86 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported that the patient presented in clinic for a bi-ventricular system implant procedure.During the implant of the novel left ventricular lead, it was noted that the lead could not smoothly be inserted through the sleeve.The physician elected to use an alternate lead to complete the procedure on (b)(6) 2020.The patient was stable.
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Manufacturer Narrative
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Analysis was normal.No anomalies were found.
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Search Alerts/Recalls
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