Model Number 1457Q/86 |
Device Problem
Failure to Capture (1081)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/21/2020 |
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 following novel system implant.During threshold testing, it was found that the patient's left ventricular lead was failing to capture.No intervention was performed.The patient was recovering.
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Manufacturer Narrative
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Correction: upon review, manufacturer report 2017865-2021-00967 for the left ventricular lead should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction and did not cause a serious event.
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Search Alerts/Recalls
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