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

Model Number 1458Q/86

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

Patient Problems Dyspnea (1816); Fatigue (1849)

Event Date 03/01/2024

Event Type  Injury  

Manufacturer Narrative

The reported events were lead dislodgement and loss of capture.The 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.

Event Description

It was reported that on (b)(6) 2024 the patient presented to the hospital feeling fatigued and out of breath.Device interrogation revealed loss of capture on the left ventricular (lv).X-ray was performed and revealed lv lead dislodgement.The physician elected to explant and replace the lv lead.There were no patient consequences.

• 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: 18941232
• MDR Text Key: 338135649
• Report Number: 2017865-2024-35466
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 1458Q/86
• Device Lot Number: A000105461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2021
• 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
• Treatment: DURATA RV LEAD; TENDRIL RA LEAD; UNIFY ASSURA ICD
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male