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Model Number TPW32 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent a temporary epicardial pacing on (b)(6) 2021 and suture was used.During the procedure, there was fraying/fracture at the point where the flexible pacing wire meets the rigid metal pin.Flexible pacing wire became completely disconnected from metal pin (portion where pacing wires connect to cables that connect to pacing box).There were no patient consequences reported.Additional information was requested.
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Manufacturer Narrative
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Product complaint number: (b)(4).(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.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: was any surgical intervention performed due to the event? if yes, date and details were pacing wires removed in re-operation? please specify.If available, please provide a product lot number.Procedure name? 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 this medwatch report is in response to receipt of a voluntary medwatch report: (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).Date sent to the fda: 3/23/2022.H6 component code: g07002 no device return.Additional information was requested, the following was obtained: additional information received via email from hcp: was any surgical intervention performed due to the event? no.If yes, date and details n/a.Were pacing wires removed in re-operation? please specify.N/a.If available, please provide a product lot number.Not available procedure name? temporary pacing.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.
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Search Alerts/Recalls
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