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

Model Number 1458QL/86

Device Problem Capturing Problem (2891)

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

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2023-48117.Related manufacturer reference number: 2017865-2023-52725.It was reported a patient's atrial lead presented with under-sensing.P-wave amplitude variation, high capture threshold, and high pacing impedance were also noted.The patient was brought in clinic and the p-waves were low or not sensed, the physician alleged the atrial lead was likely dislodged.Programming changes were made to restore normal parameters.The patient was stable.Later, the patient appeared in clinic and their atrial lead presented with loss of capture due to dislodgement, confirmed via x-ray.The leads were twisted up together near the header and the right ventricular (rv) lead had no slack.The left ventricular (lv) lead had high capture thresholds.The patient had an atrial lead revision on 8 nov 2023, in which the atrial lead helix was difficult to extend and unable to retract so that lead was removed and a new atrial lead was placed.A stylet was used to give the rv lead additional slack and no further changes were reported.Post-procedure the patient was stable.

• 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: 18156432
• MDR Text Key: 328368352
• Report Number: 2017865-2023-52724
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/16/2023

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: 1458QL/86
• Device Lot Number: A000120469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 87 KG