MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3369-40Q

Device Problem Failure to Charge (1085)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

It was reported that an implantable cardioverter defibrillator (icd) received an alert for capacitor charge time limit reached.This was discovered during stock rotation, and thus there was no patient involvement.

Manufacturer Narrative

The reported event of charge time out was confirmed.The device was above the elective replacement indicator (eri) upon receipt.The device's hv capacitors were tested in the lab and found to be normal.The device's battery was analyzed by its manufacturer and no anomalies related to charge timeout were found.The root cause of the reported event could not be determined.Please note this report submission is not late.The report is resubmitted per the request from the fda, due to missing 3rd acknowledgement.This is caused by an fda esg server issue from september 21 ¿ 23, 2022.This issue is documented in help ticket (b)(4).The initial submission attempt was performed on september 23, 2022.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15007294
• MDR Text Key: 303235210
• Report Number: 2017865-2022-14898
• 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,Followup
• Report Date: 10/21/2022

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
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000122966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2022
• 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