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

Model Number 1458Q/86

Device Problems Failure to Disconnect (2541); Detachment of Device or Device Component (2907)

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

Event Date 05/13/2022

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, the stylet was unable to be disconnected from the lead and the connector pin was detached from the lead.The lead was not used and replaced during the procedure.The patient was stable throughout.

Manufacturer Narrative

The reported events of ¿stylet was stuck in the lead and the inner lumen (along with pin) came out¿ were confirmed.As received, a complete lead was returned in one piece with stylet stuck inside the lead.The cause of the reported events was due to bunching of inner coil and ptfe coating of the stylet distal to connector pin.Electrical testing found no anomalies.No other anomalies were noted except for 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: 14539123
• MDR Text Key: 292984149
• Report Number: 2017865-2022-11269
• 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: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2022
• 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: A000123567
• 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: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Female