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

Model Number 1458Q/86

Device Problems Capturing Problem (2891); Device Dislodged or Dislocated (2923)

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

Event Date 02/07/2024

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic on (b)(6) 2024, and it was noted that there was no capture on the left ventricular (lv) lead on all vectors.Prior to the procedure, testing revealed the left ventricular lead was capturing the atrium on a vector.Chest x-ray prior to the procedure was hard to visualize.Fluoroscopy revealed lv lead dislodgement close to the coronary sinus (cs).When the pocket was opened for the procedure, the physician didn't see any suture and stated the wrong suture may have been used or the lead had not been tied down.The lv lead was explanted and replaced successfully.The patient was stable before, during and after the procedure.

Manufacturer Narrative

The reported events were lead dislodgement and loss of capture.As received, a complete lead was returned in one piece.S-curve height of the lead was measured within specification.The reported event of loss of capture was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual examination of the lead did not find any 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: 18871395
• MDR Text Key: 337290262
• Report Number: 2017865-2024-34473
• 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
• Report Date: 03/08/2024

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: A000137130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2023
• 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: GALLANT HF ICD; MRI CONDITIONAL TENDRIL LEAD; OPTISURE MRI LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 104 KG