Model Number 1458Q/86 |
Device Problems
Difficult to Advance (2920); Material Twisted/Bent (2981)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/25/2019 |
Event Type
malfunction
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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.
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Event Description
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During an implant procedure, prior to insertion into the patient, a guidewire and stylet were unable to be inserted into the left ventricular (lv) lead.The lv lead body was examined and was kinked.The lv lead was replaced.The patient was stable and will continue to be monitored.
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Manufacturer Narrative
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As received, a complete lead was returned in one piece for analysis.Visual inspection revealed the inner coil was compressed/ kinked at the middle region.The stylet and guidewire were unable to be inserted due to the compressed/kinked middle region of the lead.The cause of the reported events was isolated to a damaged inner coil that was consistent with procedural damage.
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Search Alerts/Recalls
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