MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458QL/86

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

Patient Problems Death (1802); Unspecified Infection (1930); Cardiac Tamponade (2226); Cardiogenic Shock (2262)

Event Date 03/13/2020

Event Type  Death  

Manufacturer Narrative

This product is registered as a combination product.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

Related manufacturer reference number: 2017865-2020-04331.Related manufacturer reference number: 2017865-2020-04332.Related manufacturer reference number: 2017865-2020-04337.It was reported that the patient presented in the hospital with pericarditis.The physician noted that the implantable cardioverter defibrillator, right atrial lead, right ventricular lead, or left ventricular lead could have contributed to the infection.An echocardiogram was performed on (b)(6) 2020 and revealed that the patient had developed cardiac tamponade.An emergent pericardiocentesis was performed on (b)(6) 2020, as well as a right ventricular lead revision.The patient continued to decline after procedure, experienced cardiogenic shock, and deceased on (b)(6) 2020.

Event Description

New information received notes that the physician alleged micro-perforation by the right ventricular lead.The patient experienced acute haptic necrosis that led to coagulopathy and developed hemorrhhagic conversion of pericarditis.The cause of death was liver failure and not attributed to the device or leads.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9965573
• MDR Text Key: 187845013
• Report Number: 2017865-2020-04333
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510219
• UDI-Public: 05414734510219
• 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: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 1458QL/86
• Device Catalogue Number: 1458QL/86
• Device Lot Number: A000091860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; QUADRA ASSURA MP ICD; TENDRIL STS
• Patient Outcome(s): Death; Other
• Patient Age: 50 YR
• Patient Weight: 73