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

Model Number CD3365-40C

Device Problems Intermittent Capture (1080); Over-Sensing (1438)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Further information was requested but was not yet available.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 crosstalk was observed on the implantable cardiac defibrillator.

Event Description

New information received notes the patient was having 2-3 second pauses on telemetry due to pacemaker inhibition while in hospital following knee surgery.Programming changes to sensitivity were made and to prevent pauses and inhibition.The physician was to continue monitoring the patient.The patient did not state they were having any symptoms as a result of the observation.

• Brand Name: QUADRA ASSURA CRT-D QUAD 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: 11860292
• MDR Text Key: 251843302
• Report Number: 2017865-2021-18693
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508261
• UDI-Public: 05414734508261
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: CD3365-40C
• Device Catalogue Number: CD3365-40C
• Device Lot Number: A000016785
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR