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

Model Number 1458Q/86

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Dyspnea (1816); Discomfort (2330)

Event Date 09/05/2023

Event Type  Injury  

Event Description

Related manufacturer report number: 2017865-2023-47179.It was reported that the patient presented to the emergency room with a complaint of palpitations, and shortness of breath.An electrocardiogram showed loss of left ventricular capture.A subsequent chest x-ray revealed that the left ventricular (lv) lead had dislodged.The patient was scheduled for revision.During the procedure the setscrew of the implantable cardioverter defibrillator was loosened and fell out of the device header, and onto the floor.Both the lv lead and device were explanted and replaced.The patient was discharged in stable condition.

Manufacturer Narrative

The lead was returned due to dislodgement.As received, a complete lead was returned in one piece.The s-curve height of the lead was measured within specification.Visual inspection did not find any anomalies on the lead except for the damage found consistent with procedure damage.

• 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: 17832067
• MDR Text Key: 324430951
• Report Number: 2017865-2023-47178
• 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: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• 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: A000134889
• 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: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2022
• 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
• Treatment: OPITSURE; TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 70 KG