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

Model Number 1458Q/75

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

Patient Problems Death (1802); No Code Available (3191)

Event Date 12/19/2017

Event Type  Death  

Manufacturer Narrative

(b)(4); watershed stroke; cardio embolic stroke.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 to the hospital for subtherapeutic international normalized ratio of 1.18.The patient became unresponsive during the ct scan and neurology and pulmonology were consulted and meningitis and encephalitis were a concern.The patient was started on a broad spectrum of antibiotics but the patient's condition continued to deteriorate.Infection was ruled out and the antibiotics treatment was stopped.The patient's neurological exam was consistent with a watershed area stroke, likely cardioembolic.The ct scan did not reveal any abnormalities and an mri test could not be performed due to the patient's lvad.On (b)(6) 2017 the patient's family elected to withdraw care due to the patient's condition and the patient deceased.There is no known allegation from a health care professional that suggests that the death was device related.The cause of death was unknown.No additional information was reported.

• 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: 7231990
• MDR Text Key: 98702555
• Report Number: 2017865-2018-01767
• 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: Physician
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: 1458Q/75
• Device Lot Number: 3807726
• Other Device ID Number: 05414734503334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2012
• 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: 2088TC/52, (B)(4); 7120Q/58, (B)(4); CD3265-40Q, (B)(4)
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 49 YR