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

Model Number 1258T/86

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

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

Event Date 11/11/2014

Event Type  Injury  

Event Description

It was reported that the patient was seen in the hospital the evening after implant of the left ventricular lead.The patient was syncopal and experiencing muscle stimulation.The lead exhibited loss of capture; imaging revealed that the lead had dislodged.On (b)(6) 2014, the lead was repositioned and the patient was discharged the following day.

Manufacturer Narrative

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

• Brand Name: QUICKFLEX MICRO 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: 4387533
• MDR Text Key: 20459869
• Report Number: 2017865-2015-00546
• 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

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: 08/31/2016
• Device Model Number: 1258T/86
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR