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Catalog Number TPWUNK |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number & product code? this medwatch report is in response to receipt of maude event report: (b)(4).
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Event Description
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It was reported that a patient underwent a temporary pacing in 2022 and suture was used.During the procedure, per user facility medwatch form, (b)(4), during a temporary pacing, atrial pacing wire broke and the wire was stripped to make it functional.The device is not available for return.No adverse patient consequences were reported.No additional information was requested.
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Search Alerts/Recalls
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