Catalog Number AI-07155-IK |
Device Problem
Failure to Capture (1081)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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Temporary pacemaker catheter inserted but would not capture.As a result, the catheter was removed and second one was inserted with capture.There was no report of patient complications, serious injury or death.
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Event Description
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Temporary pacemaker catheter inserted but would not capture.As a result, the catheter was removed and second one was inserted with capture.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of pacing catheter low/no signal is not confirmed.The returned device passed functional test specifications.During functional testing, both the distal and proximal electrodes met product specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Search Alerts/Recalls
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