MAUDE Adverse Event Report: ABBOTT QUARTET LEAD DOUBLE BEND, 86 CM; Drug eluting permanent left ventricular (lv) pacemaker electrode

Model Number 1457Q/86

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that during the implant procedure, the guidewire was difficult to remove from the left ventricular (lv) lead resulting in lead damage.The lv lead was explanted and replaced to resolve the event.The patient was in stable condition.

Event Description

Additional information received indicates the physician alleges the difficulty removing the guidewire from the lead was due to the guidewire and unrelated to the performance of the lead.Additionally, the physician alleges the lead damage was due to excess force required to remove the guidewire from the lead and does not allege a malfunction of the lead caused nor contributed to the lead damage.There is no allegation of malfunction on the lead.

• Brand Name: QUARTET LEAD DOUBLE BEND, 86 CM
• 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: 18940860
• MDR Text Key: 338132560
• Report Number: 2017865-2024-35457
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734510189
• UDI-Public: 05414734510189
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1457Q/86
• Device Lot Number: A000116374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2021
• 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