Model Number 1457Q/86 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Failure to Disconnect (2541)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2021 |
Event Type
malfunction
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Event Description
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During an implant procedure, the left ventricular (lv) lead was unable to be disconnected from the catheter.The lv lead was explanted and replaced to resolve the event.The patient was stable.
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Manufacturer Narrative
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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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Additional information was received indicating that an incorrect size of introducer was used to insert the left ventricular (lv) lead.The introducer was too small for the lv lead and, therefore, the lv lead became stuck.The lv lead was replaced to resolve the event and the patient was stable.
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Search Alerts/Recalls
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