Related manufacturer reference number: 2017865-2022-47964 it was reported that the patient presented for an implant procedure.During the procedure, it was noted that the wrench was unable to tighten the set screw and left ventricle (lv) lead in the pacemaker header.Upon attempting to remove the lv lead from the header, the lead connector pin was broken in the pacemaker header.The pacemaker and lv lead was not used.The physician continued with the second pacemaker and lv lead and completed the procedure.The patient was in stable condition.
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Correction: the correct analysis conclusion should have been "the reported events were ¿connector pin broke off in the header¿ and failure to removed lead from the header.A complete lead was returned in two pieces.Dimensional analysis found the diameters of the connector pin, connector ring electrodes, and the connector seal zones found to be within specification.The reported event of ¿connector pin broke off in the header¿ was confirmed.Visual inspection of the lead found that the connector pin and connector cap were pulled out of the connector assembly along with the inner coil which is consistent with procedural damage.The cause of the reported event of ¿connector pin broke off in the header¿ was due to excessive forces resulted in the connector pin and cap to be pulled out of the connector assembly consistent with procedural damage.A device history record (dhr) review was performed, and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.", rather than "the reported events were ¿connector pin broke off in the header¿ and failure to removed lead from the header.A partial lead was returned in one piece.Dimensional analysis found the diameters of the connector ring electrodes and the connector seal zones were within specification.The connector pin could not be measures due to connector pin not returned with the lead which is consistent with procedural damage.The reported event of ¿connector pin broke off in the header¿ was confirmed.Visual inspection of the lead found that the connector pin and connector cap were pulled out of the connector assembly along with the inner coil which is consistent with procedural damage.The cause of the reported event of ¿connector pin broke off in the header¿ was due to excessive forces resulted in the connector pin and cap to be pulled out of the connector assembly consistent with procedural damage.A device history record (dhr) review was performed, and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.".
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