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

Model Number CD3365-40Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Fatigue (1849); Fever (1858); Weakness (2145); Chills (2191); Malaise (2359)

Event Date 09/19/2018

Event Type  Injury  

Event Description

It was reported that the patient developed discomfort around his implantable cardioverter defibrillator pocket and his left arm early (b)(6) 2018.After about 3 weeks he developed fever, malaise, weakness, chills and fatigue.On (b)(6) 2018, he was admitted to the hospital and was diagnosed with (b)(6) bacteremia.Transesophageal echocardiography was performed and showed a small mobile echodensity on the right ventricular lead.On (b)(6) 2018, the implantable cardioverter defibrillator, atrial lead, right ventricular lead, and left ventricular lead were extracted successfully.The patient remained in stable condition throughout the procedure and no immediate complications were noted.

Manufacturer Narrative

The reported field event of infection caused or contributed by the device was not confirmed.The device was tested on the bench and no anomalies were found.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8174755
• MDR Text Key: 130676600
• Report Number: 2017865-2018-19116
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508292
• UDI-Public: 05414734508292
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: CD3365-40Q
• Device Catalogue Number: CD3365-40Q
• Device Lot Number: 4844724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2014
• 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
• Treatment: 1458Q/86, (B)(4); 1999/52,(B)(4); 7121Q/65, (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR