MAUDE Adverse Event Report: ABBOTT UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3361-40C

Device Problems Failure to Deliver Shock/Stimulation (1133); Incorrect Interpretation of Signal (1543); Under-Sensing (1661)

Patient Problem Death (1802)

Event Date 10/05/2020

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

The patient was experiencing ventricular tachycardia (vt) which degraded to ventricular fibrillation (vf) in a non-clinical environment.The device successfully delivered multiple high voltage (hv) therapies, however, was not able to revert to sinus rhythm.Following the hv therapy, the agonal rhythm, due to the patient's dying heart, was undersensed which caused sinus intervals that forced the only discriminator on, interval stability with sih, to indicate supraventricular tachycardia (svt) which caused hv therapy to be withheld.The physician and technical support reviewed the records and indicated the device behaved appropriate based on programmed settings.There was no known coroner's investigation and primary cause of death is not known.The device will not be returned for analysis as the physician does not believe the device malfunctioned.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10762626
• MDR Text Key: 213872435
• Report Number: 2938836-2020-08876
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2020

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: 09/30/2017
• Device Model Number: CD3361-40C
• Device Lot Number: P000016166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2015
• 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