Model Number 1458Q/86 |
Device Problems
Difficult to Insert (1316); Use of Device Problem (1670)
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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 11/30/2020 |
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 during an implant procedure the left ventricular lead would not stay in the patient's vein.The lead was replaced to complete the procedure.Patient had no symptoms and was stable after the event.
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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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