MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; NO MATCH

Model Number CD3357-40Q

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Dizziness (2194)

Event Type  Injury  

Event Description

It was reported that the patient's implantable cardioverter defibrillator failed to deliver shock during a tachycardia episode, resulting in patient dizziness.The device was explanted and replaced.There were no patient consequences.

Manufacturer Narrative

The reported event of hv output anomaly could not be confirmed.Final analysis of the device did not reveal any anomaly that could contribute to the reported event.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.No issues were found.

• Brand Name: UNIFY ASSURA CRT-D 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: 18004434
• MDR Text Key: 326500709
• Report Number: 2017865-2023-50617
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: CD3357-40Q
• Device Lot Number: A000092871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2020
• 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: MEDTRONIC ATRIAL LEAD.; MEDTRONIC LEFT VENTRICULAR LEAD.; MEDTRONIC RIGHT VENTRICULAR LEAD.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 100 KG