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

Model Number 1458Q/86

Device Problems Use of Device Problem (1670); Capturing Problem (2891)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

As received, a complete lead was returned in one piece for evaluation.The reported event of failure to capture was confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.The lead connector passed insertion testing into the test implantable cardioverter defibrillator (icd) device but failed to insert into the test is-4 connector sleeve.Dimensional analysis of the connector identified an over-sized diameter in a section of the connector boot.This may have contributed to the reported field events of failure to capture.

Event Description

It was reported that the patient presented for an implant procedure.It was noted that the left ventricular (lv) lead could not be fixed in the ventricle after repeated attempts and the capture threshold was elevated and the physician abandoned the use of the lv lead.It was initially beleived the patient's intrinsic anatomy, stenosis under the right clavicle affected bending of the left ventricular delivery system sheath into the right subclavian vein leading to difficulties in placing the quartet lead and high capture threshold.The patient was stable post procedure.New information from analysis indicates a manufacturing issue may have contributed to the observed high capture thresholds.

• 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: 17675002
• MDR Text Key: 322620901
• Report Number: 2017865-2023-40923
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Device Lot Number: A000132754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2022
• 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: CRT DEVICE UPGRADE; TENDRIL STS 2088TC-52