Model Number 1458Q/86 |
Device Problems
High impedance (1291); Use of Device Problem (1670); Separation Failure (2547); Capturing Problem (2891); High Capture Threshold (3266)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2020 |
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 for implant procedure.During the procedure, the left ventricular lead exhibited high capture threshold, high impedance, and stuck guidewire inside the lumen.The lead was not used.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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