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

Model Number CD3369-40Q

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

Patient Problem Discomfort (2330)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported, that during a cyber security update.A programmer was placed on a soft surface blocking the vent for the fan.Once unblocked, the programmer restarted.And the implantable cardioverter defibrillator (icd) was found to be in back up vvi mode.A firmware reset to nominal settings was performed.During this process the patient experienced mild discomfort and phrenic nerve pacing.The cyber security upgrade was eventually completed successfully.The patient was stable.

• 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: 17581354
• MDR Text Key: 321650274
• Report Number: 2017865-2023-38711
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: CD3369-40Q
• Device Lot Number: A000039284
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2017
• 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: MERLIN@HOME PROGRAMMER
• Patient Age: 80 YR
• Patient Sex: Male