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

Model Number	CD3365-40C
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented remotely via merlin net it was noted that inappropriate auto mode switching (ams) and intermittent far field r wave oversensing resulting from bigeminal premature ventricular contractions (pvcs) were observed following the biventricular pacing.Continued monitoring since the rhythm was atypical or programming changes were recommended.There were no reported patient symptoms or consequences.
Event or Problem Description
New information received notes programming changes were made to address oversensing and auto mode switching (ams).No re-occurrence was observed.A remote check on (b)(6) 2025 was normal.The patient 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 21300501
• Report Number: 2017865-2025-12190
• Device Sequence Number: 15665603
• Product Code: NIK
• UDI-Device Identifier: 05414734508261
• UDI-Public: (01)05414734508261(10)A000031104(17)181031
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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: 10/31/2018
• Device Model Number: CD3365-40C
• Device Lot Number: A000031104
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2016
• 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 ACTIVE LEAD; QUARTET LEAD; TENDRIL SDX
• Patient Age: 75 YR
• Patient Sex: Male