During an implant procedure and before the pocket closure, it was discovered that the right ventricular (rv) lead was dislodged.It was impossible to disconnect the rv lead from the header of the pacemaker.In order to resolve the event, both the rv lead and the pacemaker were replaced.Additional information was requested but is yet to be provided.The patient was stable.Related mfr # is: 2938836-2018-12288.
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The reported event of the rv-lead was stuck could not be untightened from the header was confirmed.The analysis found the rv-setscrew was firmly stuck in the connector block and required destructive methods to separate it from the device connector.Analysis performed using scanning electron microscope confirmed the foreign material found in the connector block threads to be epoxy, which caused the setscrew to get stuck.When the setscrew was tightened on the leads during the implant procedure the epoxy in the threads caused in the setscrew to be locked in place which prevented removal of the lead.A manufacturing anomaly may have occurred that left or caused the epoxy to be in the connector block threads.As a result of these findings, abbott is performing further investigation.No electrical anomalies were found.The battery voltage is above eri near bol.
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