MAUDE Adverse Event Report: ABBOTT QUICKFLEX XL LV LEAD; Drug eluting permanent left ventricular (lv) pacemaker electrode

Model Number 1158T/86

Device Problems Break (1069); High impedance (1291); Capturing Problem (2891)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

It was reported that high capture threshold and high pacing impedance was observed on the right ventricular (rv) and left ventricular (lv) lead.A rv lead fracture and lv lead damage were suspected, however, this was not confirmed via diagnostic imaging.No intervention has been performed at this time to resolve the event.The patient was in stable condition and will continue to be monitored.

• Brand Name: QUICKFLEX XL LV LEAD
• Type of Device: Drug eluting permanent left ventricular (lv) pacemaker electrode
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19160898
• MDR Text Key: 340789687
• Report Number: 2017865-2024-39345
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: 1158T/86
• Device Lot Number: 3354885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2011
• 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