MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD QUICKFLEX XL LV LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1158T/75

Device Problem Failure to Capture (1081)

Patient Problems Muscle Stimulation (1412); Syncope (1610); Dyspnea (1816)

Event Date 08/20/2013

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2013, the patient was evaluated due to syncope.Upon interrogation, the left ventricular lead exhibited loss of capture.No intervention was reported.On (b)(6) 2013, the patient presented in clinic for diaphragmatic stimulation and shortness of breath.The device was reprogrammed.No further information could be obtained.The lead was electively explanted and replaced on (b)(6) 2013 due to an unrelated issue.

Manufacturer Narrative

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

• Brand Name: QUICKFLEX XL LV LEAD
• 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: 4583745
• MDR Text Key: 5341940
• Report Number: 2017865-2015-03581
• 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: Consumer
• Reporter Occupation: Other
• Remedial Action: Notification
• 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: 06/30/2014
• Device Model Number: 1158T/75
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z1483
• Patient Sequence Number: 1
• Treatment: (B)(4)
• Patient Age: 39 YR