MAUDE Adverse Event Report: ABBOTT QUICKFLEX MICRO LV LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1258T/86

Device Problem Failure to Capture (1081)

Patient Problem Cardiac Perforation (2513)

Event Date 05/20/2022

Event Type  Injury  

Event Description

During an in clinic follow-up, loss of capture was observed on the left ventricular (lv) lead.A small thoracotomy was performed and a cardiac perforation was observed.The lv lead was capped and an epicardial lead was implanted to resolve the event.The patient was in stable condition.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Type of Device: PERMANENT 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14603523
• MDR Text Key: 293364655
• Report Number: 2017865-2022-11195
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734502610
• UDI-Public: 05414734502610
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: 1258T/86
• Device Catalogue Number: 1258T-86
• Device Lot Number: 3917195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2013
• 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; Other