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

Model Number 1158T/86

Device Problem Failure to Capture (1081)

Patient Problems Syncope (1610); Dizziness (2194)

Event Date 04/17/2015

Event Type  malfunction  

Event Description

It was reported that the dependent patient presented to the er after experiencing dizziness and passing out.The patient had syncopal episodes for the past month.Loss of capture was observed.When capture threshold tests were performed, capture returned with normal values, and the loss of capture could not be reproduced.It was suspected that the lv lead was not capturing due to programming setting.Lv lead remains implanted.Patient is fine.

Manufacturer Narrative

(b)(4).

• Brand Name: QUICKFLEX XL LV LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 4876279
• MDR Text Key: 15959530
• Report Number: 2938836-2015-26844
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Model Number: 1158T/86
• Device Lot Number: 0002662247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2008
• 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: 85 YR