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Catalog Number TPW10 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2023 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent a pacemaker procedure on (b)(6) 2023 and suture was used.During the procedure, it was reported that the very fragile wire breaks easily, and it is not possible to connect to the pacemaker generator.The hospital has 21 units in stock.No adverse patient consequences were reported.Additional information was requested.
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Manufacturer Narrative
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Product complaint # (b)(4) h6 component code: g07002 - device not returned 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts have been made to retrieve the device.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.
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Search Alerts/Recalls
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