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

Model Number CD3371-40QC

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

Patient Problems Death (1802); Endocarditis (1834); Unspecified Infection (1930); Staphylococcus Aureus (2058)

Event Date 05/06/2018

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 was admitted to the hospital due to acute and subacute bacterial endocarditis.The potential cause was (b)(6).The patient was a known (b)(6) carrier years before implant.The patient was discharged and sent home on (b)(6) 2018.No further information could be obtained.

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

New information received stated that after the implantable cardioverter defibrillator was explanted on (b)(6) 2018, the patient passed away on (b)(6) 2018.

Manufacturer Narrative

Correction: should not contain "death" as an adverse event and should not have a death date.Please disregard the event of death in the previous report.The patient had an implantable cardioverter defibrillator system removal on (b)(6) 2018 and was terminated from the study on (b)(6) 2018.The patient did not pass away.Type of reportable event should be serious injury.(b)(4).

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7655517
• MDR Text Key: 112916259
• Report Number: 2017865-2018-09677
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: CD3371-40QC
• Device Catalogue Number: CD3371-40QC
• Device Lot Number: A000041721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 01/21/2020; 03/09/2020
• Supplement Dates FDA Received: 02/10/2020; 03/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2017
• 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); 2088TC/52, (B)(4); 7122Q/65, (B)(4)
• Patient Outcome(s): Death; Hospitalization; Required Intervention