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); Detachment of Device or Device Component (2907)

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

Event Date 09/24/2021

Event Type  malfunction  

Event Description

It was reported that during implant, the stylet was stuck in the left ventricular (lv) lead.When the physician attempted to remove the stylet, the terminal pin and inner lumen was detached from the lead, and the inner lumen was exposed.The physician elected to use a different lead to complete the procedure.The patient was discharged from the hospital after the procedure.

Manufacturer Narrative

The reported events of ¿inner lumen exposed, stylet was stuck in the lead, the terminal pin and inner lumen disengaged from the lead¿ were confirmed.As received, a complete lead was returned in two pieces with the stylet stuck inside the connector portion of the lead.Visual inspection found the connector pin and connector cap were pulled out of the connector assembly and the inner coil was stretched consistent with excessive forces during procedure.The ptfe coating of the stylet was found bunched up/clogged inside the inner coil distal to the connector pin.The cause of the reported events was due to bunched up ptfe coating of the stylet that prevented the removal of the stylet and excessive forces resulted in the connector pin and cap to be pulled out of the connector assembly.A review of the device history record (dhr) confirmed that no issues were identified related to this reported event.

• 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: 12624807
• MDR Text Key: 276174627
• Report Number: 2017865-2021-32943
• 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
• Report Date: 12/17/2021

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 Expiration Date: 05/31/2024
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000111741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 83 KG