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

Model Number CD3365-40Q

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2023

Event Type  malfunction  

Event Description

This report is to advise of an event observed during analysis.

Manufacturer Narrative

The device at elective replacement indicator (eri) was returned without identified device or use problem.A malfunction based on analysis was found.A longevity calculation was performed and found the battery depletion was premature based on the device usage.Electrical testing revealed high current drain.An anomalous hybrid was found to be the cause of the high current drain and premature battery depletion.No other anomalies were found.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Type of Device: 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: 17918324
• MDR Text Key: 325454231
• Report Number: 2017865-2023-48436
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508292
• UDI-Public: 05414734508292
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/12/2023

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: 08/31/2017
• Device Model Number: CD3365-40Q
• Device Lot Number: A000010545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2015
• 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