Model Number 09-1463-0120 |
Device Problem
Loss of Threshold (1633)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event was requested but not received.
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Event Description
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During the procedure, the stimulator would not pace through any channel and the procedure was cancelled.The cable was exchanged, the pins were adjusted and the system was restarted with no resolution.The patient was prepped and the procedure was cancelled.The patient was stable with no patient consequences.
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Manufacturer Narrative
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One ep-workmate¿ scu-signal conditioning unit (amplifier), was received for investigation.Inspection of the input and output connectors confirmed the field reported issue as the connector for the lower bank channels (57-120) shows signs of physical damage to multiple electrical contact pins on the scsi (small computer system interface) connector body.The damage indicated is consistent with connecting a damaged scsi cable into the cim connector.No functional testing was performed as the product was returned in a condition that does not permit additional testing.Based on the information provided to abbott and the investigation performed, the root cause of the reported event was isolated to physical damage to multiple electrical contacts within the small computer system interface connector.The event which resulted in the physical damage was not communicated and remains undetermined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
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Search Alerts/Recalls
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