MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; NO MATCH

Model Number CD3369-40C

Device Problem Failure to Capture (1081)

Patient Problems Fatigue (1849); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2024-00488; related manufacturer reference number: 2017865-2024-00489.It was reported that a patient presented with failure to capture and high pacing impedance noted on lefty ventricular lead.Loss of capture was noted on the patient¿s implantable cardioverter defibrillator.The right ventricular lead was found to have high defibrillation impedance and externalized conductors noted under fluoroscopy.These malfunctions contributed to the patient feeling discomfort.The right ventricular lead was not addressed, but the left ventricular lead and device were explanted on (b)(6) 2023.The patient was stable throughout.

Manufacturer Narrative

The reported field event of capture anomaly could not be confirmed in the lab.Telemetry, impedance, sensing, pacing, and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: QUADRA ASSURA MP ICD
• 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: 18461933
• MDR Text Key: 332251511
• Report Number: 2017865-2024-00490
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508346
• UDI-Public: 05414734508346
• Combination Product (y/n): N
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: CD3369-40C
• Device Lot Number: A000034537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2017
• 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: RIGHT ATRIAL LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 110 KG