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

Model Number CD3369-40C

Device Problems Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 02/29/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient presented in the emergency room after receiving high voltage therapies from their implantable cardioverter defibrillator.Upon interrogation, it was noted that the patient had a ventricular tachycardia which was appropriately converted with antitachycardia pacing.However, the patient had a ventricular tachycardia storm.Due to the antitachycardia pacing being depleted, the patient went into ventricular fibrillation.Shocks were delivered but were unable to convert the rhythm.The patient was externally defibrillated.No device intervention was performed.Patient was stable and will continue to be monitored.

Event Description

New information received indicated that it was suspected that the shock induced the ventricular fibrillation episode.

• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9863072
• MDR Text Key: 184368314
• Report Number: 2017865-2020-02990
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508346
• UDI-Public: 05414734508346
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/12/2020

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: 06/30/2018
• Device Model Number: CD3369-40C
• Device Catalogue Number: CD3369-40C
• Device Lot Number: A000024306
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/29/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 04/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2016
• 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
• Patient Outcome(s): Required Intervention