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

Model Number	CD3365-40Q
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information was requested but not received.
Event or Problem Description
It was reported that patient presented remotely via merlin.Net.Review of transmission revealed that implantable cardiac defibrillator (icd) went into back up mode.No intervention was reported.Patient condition was unknown.
Event or Problem Description
New information noted that patient presented in an emergency room experiencing diaphragmatic stimulation and it was noted that device went into back up mode.High voltage therapies were active at the time of backup mode.Programming changes were made to restore the original mode.Patient condition was stable.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Common Device Name: 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 21708312
• Report Number: 2017865-2025-38712
• Device Sequence Number: 19997646
• Product Code: NIK
• UDI-Device Identifier: 05414734508292
• UDI-Public: (01)05414734508292(10)A000013335(17)171031
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: CD3365-40Q
• Device Catalogue Number: CD3365-40Q
• Device Lot Number: A000013335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DURATA.; QUARTET,
• Patient Age: 73 YR
• Patient Sex: Male