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

Model Number 1458Q/86

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 01/19/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented in the operation room for implant procedure.During the procedure, the newly implanted left ventricular (lv) lead was found damaged, and portions of the lead was separated from the main body of the lead.The left ventricular lead was not installed and the procedure was completed using an alternate left ventricular lead on (b)(6) 2023.The patient's condition was stable.

Manufacturer Narrative

The reported event of ¿the lead is damaged and part of the lead separated from the main body of the lead¿ was confirmed.As received, a partial lead was returned in one piece measuring 86.0 cm.It was noted that the connector pin and connector cap of the lead were pulled out of the molded connector stretching and separating the inner coil of the lead which consistent with damage due to excessive forces applied during the procedure.The connector pin with the cap were missing/not returned with the lead.The cause of the reported event was 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: 16270364
• MDR Text Key: 308454564
• Report Number: 2017865-2023-04587
• 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: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• 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: A000126360
• 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: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2022
• 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