Catalog Number AI-06210-KS |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/19/2023 |
Event Type
malfunction
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Event Description
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It was reported that, "we tried to sue a temporary pacing catheter with shrouded pins/introducer kit.It was not capturing or sensing.The catheter was discarded and we got another catheter and it worked fine.We are questioning if this one was faulty".At the time of this report the customer has not returned our requests or additional information.If additional information is received, the complaint file will be updated.
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Manufacturer Narrative
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Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
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Manufacturer Narrative
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(b)(4).The reported complaint of pacing catheter "not capturing or sensing" is not able to be confirmed.The product was not returned for i nvestigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that, "we tried to sue a temporary pacing catheter with shrouded pins/introducer kit.It was not capturing or sensing.The catheter was discarded and we got another catheter and it worked fine.We are questioning if this one was faulty".At the time of this report the customer has not returned our requests or additional information.If additional information is received, the complaint file will be updated.
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Search Alerts/Recalls
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