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

Model Number 1258T/86

Device Problems Device Contamination with Body Fluid (2317); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

A complete lead was returned and dried blood was noted throughout the inner coil lumen.Visual and x-ray examination reveal damages that are consistent with those occurring at the time of the implant and explant procedure.Electrical testing did not reveal any indication of conductor fractures or internal shorts.The results of the investigation concluded the analysis of the device was normal with no anomalies found.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

During follow-up, the left ventricular lead was found to be dislodged.The lead was revised and during the replacement procedure, blood was noted on the lv channel of the header.The lead was explanted and replaced and the patient was in stable condition.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 6980134
• MDR Text Key: 90335539
• Report Number: 2017865-2017-32986
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 1258T/86
• Device Lot Number: A000028628
• Other Device ID Number: 05414734502610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• 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): Hospitalization; Required Intervention