Catalog Number AI-06210 |
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 10/13/2021 |
Event Type
malfunction
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Event Description
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It was reported that when the doctor placed a pacemaker introducer number 7.0, it did not capture adequately.It was noted that several attempts were made, and no capture was achieved.As a result, it was changed to another electrode.There was no report of delay in therapy.There was no report of patient complication, serious injury, or death.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Qn# (b)(4).The product was not returned for investigation.The reported complaint of pacing catheter low/no signal is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.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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Event Description
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It was reported, that when the doctor placed a pacemaker introducer number 7.0.It did not capture adequately.It was noted, that several attempts were made, and no capture was achieved.As a result, it was changed to another electrode.There was no report of delay in therapy.There was no report of patient complication, serious injury, or death.
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Search Alerts/Recalls
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