MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA CRT-D QUAD RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3365-40Q

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate or Unexpected Reset (2959)

Patient Problem Discomfort (2330)

Event Date 12/23/2021

Event Type  malfunction  

Event Description

It was reported that a symptomatic patient presented with muscle stimulation in clinic for follow up.Device interrogation revealed back up operation due to event queue overflow on the implantable cardioverter defibrillator (icd).Programming changes were performed to resolve the issue. the patient condition was stable.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13113098
• MDR Text Key: 283147340
• Report Number: 2017865-2021-40183
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: CD3365-40Q
• Device Catalogue Number: CD3365-40Q
• Device Lot Number: A000011419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2015
• 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: 1688TC/52 TENDRIL SDX ATRIAL; 1688TC/52 TENDRIL SDX LEFT VENTRICLE; 7120Q/65 DURATAACTIVE RIGHT VENTRICLE
• Patient Age: 71 YR
• Patient Sex: Male