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

Model Number CD3369-40Q

Device Problem Intermittent Capture (1080)

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

Event Date 01/02/2021

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 patient presented remotely.Upon review, the implantable cardioverter defibrillator exhibited intermittent loss of capture.No intervention was performed.The patient was asymptomatic.

Event Description

Related manufacturer reference number: 2017865-2021-12167.New information received notes the right ventricular lead was repositioned on (b)(6) 2021 for the event of intermittent loss of capture.The patient was in stable condition.

• Brand Name: QUADRA ASSURA MP 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: 11246150
• MDR Text Key: 229324813
• Report Number: 2017865-2021-06013
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508377
• UDI-Public: 05414734508377
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000103747
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPTISURE ACTIVE FIXATION
• Patient Age: 82 YR
• Patient Weight: 80