MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) QUARTET; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Model Number	1458Q/86
Medical Device Problem Codes	High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing phrenic nerve stimulation (pns) due to the left ventricular (lv) lead.Additionally, increased pacing impedance was observed on the lv lead.The lead was explanted and replaced.Visually twisting of the lead body was observed.The patient was in stable condition.

• Brand Name: QUARTET
• Common Device Name: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50813201
• Report Number: 2017865-2026-19802
• Device Sequence Number: 10648374
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: (01)05414734503198(10)S000089506(17)260131
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 1458Q/86
• Device Lot Number: S000089506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown