MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3361-40C

Device Problem Failure to Convert Rhythm (1540)

Patient Problems Arrhythmia (1721); Death (1802)

Event Date 10/22/2020

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

The patient passed away as the device did not deliver therapy as it classified the patient's slow ventricular tachycardia (vt) in the vt zone as atrial fibrillation due to the stability discriminator programmed.There is no alleged malfunction against the device as the healthcare provider states the device is not designed to detect slow ventricular fibrillation and was working appropriately based on the device settings.Further information was requested but not received.

Event Description

Further information was received indicating the patient had known dilated cardiomyopathy with recent episodes of ventricular tachycardia (vt).The patient was awaiting ablation therapy.On (b)(6) 2020, the patient was in the hospital following a collapse due to vt and progressive shortness of breath.The healthcare professional believes the symptoms were due to progressive heart failure and was treated with a diuretic.Then on (b)(6) 2020, the patient was found unresponsive at home and had passed away.The patient's death was due to extensive cardiac history, recent episodes of vt due to cardiac arrhythmia secondary to known dilated cardiomyopathy.There is no allegation of device malfunction.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10788204
• MDR Text Key: 214655067
• Report Number: 2938836-2020-09058
• Device Sequence Number: 1
• Product Code: NIK
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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: 09/30/2018
• Device Model Number: CD3361-40C
• Device Lot Number: A000029404
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death