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

Model Number	CD3365-40C
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	11/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient presented with asystole due to inhibition of pacing from far p oversensing.No changes were reported.The patient was stable.
Event or Problem Description
New information received notes the patient's implantable cardioverter defibrillator (icd) was explanted and replaced in a procedure on (b)(6) 2023.The patient status was unknown.
Additional Manufacturer Narrative
The reported event of far r oversensing was confirmed by reviewing the device data.However, the reported event was caused by external (non-device related) factors.Interrogation of the device revealed the device was above elective replacement indicator (eri) when received.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Common Device Name: 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15970760
• Report Number: 2017865-2022-48558
• Device Sequence Number: 17371500
• Product Code: NIK
• UDI-Device Identifier: 05414734508261
• UDI-Public: 05414734508261
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 11/08/2023

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: 02/28/2018
• Device Model Number: CD3365-40C
• Device Catalogue Number: CD3365-40C
• Device Lot Number: A000018532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/25/2022
• Supplement Date Received by Manufacturer: 08/28/2023; 10/26/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 09/18/2023; 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2016
• 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: 1458Q/86 QUARTETLEAD; 1688TC/46 TENDRIL; COMPETITOR RIGHT VENTRICULAR LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 134 KG