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

Model Number 1258T/86

Device Problem Signal Artifact/Noise (1036)

Patient Problem Syncope (1610)

Event Date 12/27/2018

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 on (b)(6) 2018 due to leg pain and syncope.Pauses were noted on telemetry in the hospital.Device interrogation revealed, the right ventricular lead exhibited low amplitude r wave signals and intermittent oversensing of noise resulting in pacing inhibition.Noise could be reproduced with pocket manipulation on both the right ventricular and left ventricular leads, the noise caused the device to both inhibit pacing and register some of this noise as tachy events.It was noted that the left ventricular lead had a history of elevated thresholds and pacing impedances and had been stable and functional with these measurements for some time.The device was reprogrammed.The patient was in stable condition during the event.The leads were explanted and replaced on (b)(6) 2019.The patient was in stable condition during and post procedure.

• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8232023
• MDR Text Key: 132545617
• Report Number: 2017865-2019-00409
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734502610
• UDI-Public: 05414734502610
• 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: 01/09/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Model Number: 1258T/86
• Device Lot Number: 3402776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2011
• 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: 7121Q/52, (B)(4)
• Patient Outcome(s): Required Intervention