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 Code	No Pacing (3268)
Health Effect - Clinical Codes	Discomfort (2330); Syncope/Fainting (4411)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic due to symptoms of syncope and chest pain due to loss of pacing, the patient¿s implantable cardioverter defibrillator (icd) was found to be at elective replacement indicator (eri) and was explanted and replaced on (b)(6) 2025.No further information was provided.
Additional Manufacturer Narrative
The reported event of no lv output was not confirmed.The device voltage was at end of service (eos) upon receipt.Assessment of total projected longevity was performed, and the device was found to have exceeded estimated longevity.Analysis revealed no anomalies.Electrical tests performed including lead impedance and output verification did not identify any functional issues.

• 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: 22863485
• Report Number: 2017865-2025-98299
• Device Sequence Number: 12684057
• Product Code: NIK
• UDI-Device Identifier: 05414734508292
• UDI-Public: (01)05414734508292(10)A000012192(17)170930
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• 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): 10/27/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: CD3365-40Q
• Device Catalogue Number: CD3365-40Q
• Device Lot Number: A000012192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2015
• 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: OPTISURE.; QUARTET.; TENDRIL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male