ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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Model Number 100015555 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/05/2022 |
Event Type
malfunction
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Event Description
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During the af procedure, it was not possible to connect the neck patch.The navlink and patches were replaced, but the issue was not resolved.Later upon checking the amplifier port, bent pins were found which caused a communication issue.The procedure was cancelled.
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Manufacturer Narrative
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Additional information: g3, h2, h3 the results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information received, the cause of the reported bent pins and subsequent cancellation remains unknown.
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Search Alerts/Recalls
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