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

Model Number 1458Q/86

Device Problems Failure to Capture (1081); Failure to Sense (1559); Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

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

Event Date 08/27/2023

Event Type  Injury  

Event Description

Related manufacturing reference number: 2017865-2023-52429.It was reported that the right atrial (ra) and left ventricular (lv) leads were dislodged.The dislodged leads were discovered via fluoroscopy.The ra lead was noted to under-sense and had further device sensing issues in the form of p-wave amplitude variation.There were no electrical anomalies noted on the lv lead.The patient was asymptomatic.The physician reprogrammed the device to bvvi pacing.The patient was stable throughout the intervention.

Event Description

Related manufacturing reference number: 2017865-2023-52429.Additional information received notes that there was loss of capture and loss of sensing on the atrial lead and left ventricular (lv) lead.The physician elected to explant and replace the atrial and lv lead.The patient condition was stable before, during, and after the procedure.

• 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: 18135922
• MDR Text Key: 328130606
• Report Number: 2017865-2023-52428
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1458Q/86
• Device Lot Number: A000098738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• 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: DURATATACHY MRI LEADS; QUADRAASSURA MP ICD UMRI
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female