Model Number 1458Q/86 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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This product is registered as a combination product.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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It was reported that the patient presented for an implant procedure.During the procedure, the left ventricular lead could not be fixed.The lead was removed and replaced.The patient was in stable condition.
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Manufacturer Narrative
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Analysis found that a complete lead was returned in one piece measuring 86.4cm.Analysis was normal.No anomalies were found.
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Search Alerts/Recalls
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