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

Model Number 1458Q/86

Device Problem Separation Failure (2547)

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

Event Date 06/22/2022

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, the stylet became stuck in the left ventricular lead.The lead was removed and replaced.The patient was discharged after the procedure.

Manufacturer Narrative

Correction: section h6 ¿ investigation conclusions should be "caused traced to component failure" rather than "unintended use error caused or contributed to event".

Manufacturer Narrative

The reported event of ¿stylet became stuck in the left ventricular (lv) lead¿ was confirmed.As received, a complete lead was returned in one piece measuring 85.5 cm /89.0 cm with stylet stuck inside the lead.Visual examination found that the ptfe coating of the stylet was found stripped and was bunched up with the inner coil of the lead.The cause of the reported event was due to bunching of inner coil of the lead and ptfe coating of the stylet, and also excessive forces resulted in the connector pin and the connector cap to be pulled out of the connector assembly consistent with procedural damage.A device history record (dhr) review was performed and all required manufacturing processes and inspections 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15277261
• MDR Text Key: 304720754
• Report Number: 2017865-2022-20157
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: IS
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2022

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 Catalogue Number: 1458Q-86
• Device Lot Number: S000083427
• 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: 08/01/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 10/04/2022; 10/04/2022
• Supplement Dates FDA Received: 10/27/2022; 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• 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