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

Model Number CD3365-40Q

Device Problem Failure to Convert Rhythm (1540)

Patient Problem Death (1802)

Event Date 08/29/2020

Event Type  Death  

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 an agonal rhythm was noted on the patient's device.No shocks were delivered but 3 anti-tachycardia pacing (atp) therapies were delivered for very slow ventricular tachycardia (vt).After vt, it again went into the agonal rhythm.Physician did not allege any device malfunction and it was noted that the patient was actively dying due to other causes.The patient expired.The physician did not allege the at the device contributed to death, but it was due to agonal rhythm.The atp delivered were appropriate for vt but suspected that it did not convert the rhythm being secondary to another cause of death as per physician.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10534180
• MDR Text Key: 206930381
• Report Number: 2938836-2020-08270
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: CD3365-40Q
• Device Catalogue Number: CD3365-40Q
• Device Lot Number: 4847780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2014
• 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): Death