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

Model Number CD3357-40Q

Device Problems Failure to Capture (1081); Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2023

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2023-02857.It was reported that the patient presented in clinic for follow up.Upon device interrogation, the right ventricular (rv) lead exhibited under-sensing, loss of sensing and capture.The lead was capped and replaced on (b)(6) 2023.During the same procedure, after the right ventricular lead was replaced, the implantable cardioverter defibrillator exhibited loss of sensing and capture.The device was explanted and replaced.The patient condition was stable.

Manufacturer Narrative

The reported field event of under sensing and failure to capture could not be reproduced during analysis.Telemetry, impedance, sensing, pacing, and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16233222
• MDR Text Key: 308014528
• Report Number: 2017865-2023-02858
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508216
• UDI-Public: 05414734508216
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: CD3357-40Q
• Device Catalogue Number: CD3357-40Q
• Device Lot Number: A000042601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2017
• 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
• Treatment: QUICKFLEXMICRO; TENDRIL
• Patient Age: 34 YR
• Patient Sex: Male