MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problem High Capture Threshold (3266)

Patient Problem Syncope (1610)

Event Date 10/20/2014

Event Type  malfunction  

Event Description

It was reported that the patient presented in hospital with syncopal episodes.Upon interrogation, the left ventricular lead exhibited high capture thresholds.The pacing vector was changed and the lead remained implanted.The patients condition was satisfactory after the procedure and would be followed up routinely.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jennie hamel ; 15900 valley view court; sylmar, CA 91342 ; 8184933462
• MDR Report Key: 4388302
• MDR Text Key: 17587205
• Report Number: 2017865-2015-00798
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 1458Q/86
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2014
• 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: (B)(4)
• Patient Age: 71 YR