MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; NO MATCH

Model Number 1458Q/86

Device Problems Separation Failure (2547); Capturing Problem (2891); Device Dislodged or Dislocated (2923)

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

Event Date 08/08/2023

Event Type  malfunction  

Event Description

It was reported that lead parameters were initially good during implant of the left ventricular (lv) lead, however after the sheath was removed there was a slight change in position.The capture thresholds were increased.The physician attempted to insert a guidewire into the lv lead to try and adjust its position.When the guidewire was inserted, it was found the guidewire was stuck in the electrode and could not be removed.The lv lead was removed and replaced.There were no patient consequences.

Manufacturer Narrative

The reported events were lead dislodgement, high pacing threshold and stylet could not be removed.As received, a complete lead was returned in one piece with the stylet stuck inside the lead.The reported event of high pacing threshold was not confirmed while the reported event of stylet could not be removed 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 and the ptfe stylet coating was bunched up/clogged with the inner coil distal to the connector pin.The cause of the reported event of stylet could not be removed was due to bunched up polytetrafluoroethylene (ptfe) coating of the stylet inside the inner coil that prevented the removal of the stylet and excessive forces resulted in the connector pin and crimp sleeve to be pulled out of the connector assembly.Electrical testing did not find any indication of conductor fractures or internal shorts.The full measured s-curve hump height was within specification.

• Brand Name: QUARTET
• Type of Device: NO MATCH
• 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: 17628917
• MDR Text Key: 322024537
• Report Number: 2017865-2023-39359
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

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 Lot Number: A000135796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/27/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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