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

Model Number 1458QL/86

Device Problems Failure to Capture (1081); Therapy Delivered to Incorrect Body Area (1508); Failure to Advance (2524)

Patient Problem Discomfort (2330)

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported that the left ventricular (lv) capture threshold was high in multiple vectors, no capture and some diaphragmatic stimulation was noted.The lv lead was capped (b)(6) 2024 and replaced.The patient tolerated the procedure well, was recovering and was discharged.

Event Description

New information received notes that during the procedure a guidewire could not be inserted into the left ventricular (lv) lead.As previously reported the lv lead was replaced and the patient was discharged.

• 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: 18549234
• MDR Text Key: 333313471
• Report Number: 2017865-2024-01549
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510219
• UDI-Public: 05414734510219
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 1458QL/86
• Device Lot Number: S000019241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2016
• 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.; GALLANT.; TENDRIL.
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female