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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 06/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).(b)(6).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent attempts are being made to clarify 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 on 6/14 in re-operation? please specify.If available, please provide a product lot number.
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Event Description
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It was reported that the patient underwent a heart transplant surgery on (b)(6) 2021 and temporary pacing wire was used.On 6/9 the rn reported to unit cns/crn that the v wire was completely broken off from pin at connection site.Exact date of break is unknown.Pacing wires were removed on 6/14.No known harm to patient.There were no patient consequences reported.Additional information has been requested.
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Search Alerts/Recalls
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