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

Model Number 1458

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Arrhythmia (1721); Cardiopulmonary Arrest (1765); Death (1802)

Event Date 04/14/2018

Event Type  Death  

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.(b)(4).

Event Description

It was reported that the patient presented to the hospital on (b)(6) 2018 with exacerbated congestive heart failure and was discharged on (b)(6) 2018.On (b)(6) 2018, the patient became unresponsive while her husband was assisting her to a chair within their home.Ems was called and upon arrival approximately 15 minutes later, the patient was in a state of cardiac and respiratory arrest.Cpr was performed and the patient was sent to the emergency department.The patient had a pulse but was unresponsive to verbal and physical stimuli and was under assisted breathing by ventilator.The patient was deemed medically appropriate to be under dnr.On (b)(6) 2018, the patient was announced deceased and the causes of death were cardiac arrest due to arrhythmia, mitral valve regurgitation, and congestive heart failure.The patient had 2 previous procedure done in february and (b)(6) 2018.The patient had a heart catheter in place in (b)(6) and had a mitral valve clip repair procedure in (b)(6) due to severe mitral regurgitation.No further information was available at this time.

• 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
• 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: 8007670
• MDR Text Key: 125089532
• Report Number: 2017865-2018-15988
• Device Sequence Number: 1
• Product Code: OJX
• 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: company representative,health
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 71 YR
• Patient Weight: 72