MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3369-40Q

Device Problem Wireless Communication Problem (3283)

Patient Problem Arrhythmia (1721)

Event Date 02/23/2023

Event Type  Injury  

Event Description

Related manufacturer report number: 2017865-2023-13815.It was reported that the patient presented for a ventricular tachycardia (vt) ablation.During the procedure the programmer session was being used as a pacing system analyzer (psa) and therapy was disabled on the implantable cardioverter defibrillator (icd).When the staff attempted to change from the psa to programming mode, radio frequency (rf) telemetry had timed out and the connection was established via inductive telemetry and icd pacing was successfully programmed to pace only, however high voltage therapy remained disabled.The patient went into ventricular fibrillation (vf) and the physician attempted to select programmer command shock, but the screen froze and would not recover.The programmer had to be restarted while the patient was unstable in vf and new programmer session was initialized.Once restarted a programmer command shock was successfully delivered by the icd.The patient was stable.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16544926
• MDR Text Key: 311304663
• Report Number: 2017865-2023-13816
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508377
• UDI-Public: 05414734508377
• 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
• Report Date: 03/15/2023

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: 04/30/2020
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000055386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2018
• 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: QUARTET; RIGHT VENTRICULAR LEAD; TENDRIL
• Patient Outcome(s): Life Threatening
• Patient Sex: Male