MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA CRT-D QUAD RF HV; NO MATCH

Model Number CD3365-40Q

Device Problems Failure to Capture (1081); Failure to Deliver Shock/Stimulation (1133); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Syncope/Fainting (4411); Heart Failure/Congestive Heart Failure (4446)

Event Date 11/03/2023

Event Type  Injury  

Event Description

It was reported that the patient presented during procedure.During procedure, the patient went asystole because the implantable cardioverter defibrillator inhibited output while using electrical cautery.No interventions were performed.The patient's condition was unknown.

Manufacturer Narrative

The reported event of noise reversion inhibiting pacing was confirmed.Based on the information provided, it was determined that ventricular noise reversion pacing mode was set to ¿pacing off¿ and that setting remains if the pacing mode was changed.The device is performing per design.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• 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: 18207834
• MDR Text Key: 328957515
• Report Number: 2017865-2023-93166
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508292
• UDI-Public: 05414734508292
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: CD3365-40Q
• Device Lot Number: A000032141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/26/2023
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2016
• 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 LEAD; QUARTET LEAD; TENDRIL LEAD
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male