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

Model Number CD3361-40QC

Device Problems Failure to Deliver Shock/Stimulation (1133); Under-Sensing (1661)

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

Event Date 10/07/2020

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 for a follow-up in clinic.Upon interrogation, it was noted that the implantable cardioverter defibrillator exhibited failure to deliver shock due to undersensing of ventricular tachycardia and ventricular fibrillation events.Programming changes were suggested by not made.The patient was in stable condition.

Event Description

It was reported that the patient presented for a follow-up in clinic.Upon interrogation, it was noted that the implantable cardioverter defibrillator exhibited failure to deliver shock due to undersensing of ventricular tachycardia and ventricular fibrillation events.Programming changes were made and the patient was in stable condition.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10740795
• MDR Text Key: 213211516
• Report Number: 2017865-2020-16181
• 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: 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: 08/31/2019
• Device Model Number: CD3361-40QC
• Device Lot Number: S000039261
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR