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

Model Number 1458Q/86

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the patient presented for lead implant procedure.During the procedure, the left ventricle lead to be implanted exhibited detachment of device or device component.The physician did not use the lead during the procedure on (b)(6) 2022.The patient was stable.

Event Description

It was reported that the patient presented for lead implant procedure.During the procedure, the left ventricle lead to be implanted exhibited detachment of device or device component and the issue was discovered while the left ventricle lead was being pulled out of the vein and was in cusp of coronary sinus.The physician felt the tip of the left ventricle lead was loose during repositioning.The left ventricle lead was replaced during the procedure on (b)(6) 2022.The patient was stable.

Manufacturer Narrative

The reported event of ¿lv lead tip disconnection with the lead body¿ was confirmed.As received, a complete lead was returned in one piece with stylet stuck inside the lead.The ptfe coating of the stylet was found stripped and clogged in the inner coil distal to the connector pin.The connector pin and connector cap were found pulled out of the connector assembly and the inner coil was stretched consistent with excessive forces during the procedure.The cause of the reported event was isolated to procedural damage.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13996646
• MDR Text Key: 288502424
• Report Number: 2017865-2022-06970
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• 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: A000116014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• 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