MAUDE Adverse Event Report: ABBOTT QUARTET; No Match

Model Number 1458Q/86

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Arrhythmia (1721)

Event Date 03/06/2024

Event Type  Injury  

Event Description

Following implant of the left ventricular (lv) lead, the physician attempted to remove the stylet and felt resistance.The physician then removed the stylet with force resulting in detachment of the lv lead's pin and lv lead damage.Following this event, the physician recannulated the coronary sinus and this led to a ventricular arrhythmia.Atp was delivered but was not successful.The arrhythmia was terminated with successful delivery of a shock.The physician reported this additional intervention was suspected to be the cause of this arrhythmia and the patient was previously shocked three times during the procedure due to an unrelated arrhythmia.The event was resolved by explanting and replacing the lv lead.The patient was in stable condition following the procedure.

• 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: 18932831
• MDR Text Key: 338023308
• Report Number: 2017865-2024-35341
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: Other Health Care Professional
• 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 Model Number: 1458Q/86
• Device Lot Number: A000118063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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
• Patient Outcome(s): Required Intervention; Other