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

Model Number CD3357-40Q

Device Problems Incorrect Measurement (1383); Data Problem (3196)

Patient Problems Atrial Fibrillation (1729); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2020

Event Type  malfunction  

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 with an atrial fibrillation.Upon review, the implantable cardioverter defibrillator exhibited a diagnostics anomaly.Specifically, the right ventricular coil to can and superior vena cava to right ventricular coil reading was unable to be obtained.Programming changes were made.The patient was stable and will continue to be monitored.

Manufacturer Narrative

Correction: h6 medical device problem code should have been "incorrect measurement" not "data problem" add: h6 component code.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• 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: 9638617
• MDR Text Key: 176648235
• Report Number: 2017865-2020-01090
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508216
• UDI-Public: 05414734508216
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: CD3357-40Q
• Device Catalogue Number: CD3357-40Q
• Device Lot Number: A000088122
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR