MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; NO MATCH

Model Number 1458Q/86

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Dislodged or Dislocated (2923)

Patient Problem Discomfort (2330)

Event Date 12/12/2023

Event Type  Injury  

Event Description

It was reported that the patient was admitted to the hospital experiencing chest pain.Upon device interrogation, it was noted that the left ventricular lead had pulled back and was causing diaphragmatic stimulation.The lead was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported events were extra cardiac stimulation and lead dislodgement.As received, a complete lead was returned in one piece.The reported event of extra cardiac stimulation was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.The s-curve hump height was measured within specification.Visual examination found no anomalies.

• Brand Name: QUARTET
• Type of Device: NO MATCH
• 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: 18432763
• MDR Text Key: 331813202
• Report Number: 2017865-2024-00185
• 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,Followup
• Report Date: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Device Lot Number: A000134865
• 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: 12/12/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 04/04/2024; 05/21/2024
• Supplement Dates FDA Received: 04/04/2024; 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• 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
• Treatment: MRI COND TENDRIL LEAD; MRI LEAD; QUARTET LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female