MAUDE Adverse Event Report: ABBOTT QUARTET; No Match

Model Number 1458Q/86

Device Problems Failure to Capture (1081); Difficult to Remove (1528)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

During device replacement for normal battery depletion, there was difficulty removing the left ventricular (lv) lead from the header of the device.The distal pin of the lv lead remained inside the header.The physician elected to partially cut the lv lead and repair it with medical adhesive so it could successfully be inserted into the header of the new device.Loss of capture was observed following the procedure; the device was reprogrammed to resolve the event.The patient was stable following the procedure and there were no adverse consequences.

• Brand Name: QUARTET
• Type of Device: No Match
• 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: 18907519
• MDR Text Key: 337728206
• Report Number: 2017865-2024-35031
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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