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

Model Number 1458Q/86

Device Problems Break (1069); Separation Failure (2547)

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

Event Date 01/13/2024

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2024-01748.It was reported that the patient presented for a generator change procedure due to normal battery depletion.During the procedure, it was noted that the chronic left ventricular (lv) lead exhibited an elevated capture threshold.The physician intended to replace the lv lead.During the replacement, it was found that the guidewire was failing to be removed from the new lv lead.An additional attempt to remove the guidewire damaged the new lv lead.Thus, no new lv lead was implanted.Programming changes were made on the chronic lv lead to address high capture threshold.When the physician attempted to connect the chronic lv lead to the new pacemaker, it was found that the pacemaker setscrew exhibited loose connections.The pacemaker was not used.The physician continued with second new pacemaker and completed the procedure.The patient was in stable condition.

Manufacturer Narrative

The reported events of difficulty removing the wire from the lead and lead damage were confirmed.A complete lead with stuck stylet was returned in one piece.The ptfe coating of the stuck stylet was stripped and was found bunched up with the inner coil distal to the connector pin.The connector pin with the crimp sleeve were found pulled out stretching the inner coil consistent with damage due to excessive forces applied while attempting to remove the stylet from the lead during the procedure.The connector cap was intact in the connector assembly.The cause of the reported events was isolated to the bunching of the stylet ptfe coating inside the inner coil at the connector region that prevented the removal of the stylet and excessive forces resulted in the connector pin with the crimp sleeve to be pulled out of the connector assembly.Electrical testing was normal with no anomalies found.

• 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: 18568148
• MDR Text Key: 333535549
• Report Number: 2017865-2024-01749
• 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: 03/05/2024

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: A000142333
• 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: 01/13/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• 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