MAUDE Adverse Event Report: ABBOTT QUARTET; No Match

Model Number 1458Q/86

Device Problems Break (1069); Failure to Capture (1081); High impedance (1291)

Patient Problem Fatigue (1849)

Event Date 02/08/2024

Event Type  Injury  

Event Description

During an in clinic follow up, the patient noted feeling fatigue, a loss of capture and high pacing impedance was observed on the left ventricular (lv) lead.Subclavian crush was suspected.During the lead revision procedure, it was noted the lv lead was broken and a portion of the lv lead was unable to be removed.An additional procedure was performed and the remainder of the lv lead was explanted and a new lv lead was implanted.The patient was stable.

Manufacturer Narrative

The reported events of high pacing lead impedance, lead fracture, failure to capture and suspected subclavian crush were confirmed.As received, a complete lead was returned in two pieces.A clavicular crush damage was found at the middle region of the lead damaging the lead body and fracturing the conductor cables and all the filars of the inner coil.Electrical testing did not find any indication of internal shorts.The cause of the reported events was due to clavicular crush damaged.

• 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: 18935420
• MDR Text Key: 338066048
• Report Number: 2017865-2024-35376
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: PO
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 1458Q/86
• Device Lot Number: S000063850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2018
• 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
• Treatment: ISOFLEX OPTIM LEAD; ISOFLEX OPTIM LEAD
• Patient Outcome(s): Required Intervention