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

Model Number 1258T/86

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Death (1802)

Event Date 06/27/2017

Event Type  Death  

Event Description

It was reported that the patient presented in the emergency room after experiencing multiple ventricular arrhythmias.The cardiac resynchronization therapy defibrillator delivered therapy initially.The device failed to deliver defibrillation therapy for the later ventricular arrhythmias.Upon interrogation, the device had reached elective replacement indicator because of premature battery depletion the same day.The patient had to be defibrillated externally.The patient became clinically unstable and later died during the day.

• Brand Name: QUICKFLEX MICRO LV LEAD
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6686061
• MDR Text Key: 79050710
• Report Number: 2017865-2017-05943
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 1258T/86
• Device Lot Number: S000009327
• Other Device ID Number: 05414734502610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2015
• 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: 7120/65, CED026823; CD3235-40, 1208505
• Patient Outcome(s): Death; Required Intervention