MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Break (1069); Difficult to Remove (1528); Connection Problem (2900); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.".

Manufacturer Narrative

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.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15929774
• MDR Text Key: 306994699
• Report Number: 2017865-2022-47966
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000128047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 01/13/2023; 01/26/2023
• Supplement Dates FDA Received: 01/15/2023; 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female