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

Model Number	1458QL/86
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an implant procedure, the patient had only one suitable coronary sinus (cs) branch available for left ventricle (lv) lead placement.After initial placement, the only pacing vector that did not produce phrenic nerve stimulation (pns) was d1-m3.However, the physician noted that d1-m3 was not available as a programmable pacing vector on the pm3562 device.During pocket closure, the lv lead dislodged as observed under fluoroscopy and required repositioning.Following repositioning, the d1-p4 vector achieved capture without pns, allowing successful completion of the procedure.The patient was stable.

• 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: 50928102
• Report Number: 2017865-2026-20579
• Device Sequence Number: 10739578
• Product Code: NIK
• UDI-Device Identifier: 05414734510219
• UDI-Public: (01)05414734510219(10)A000189313(17)290531
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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 Model Number: 1458QL/86
• Device Lot Number: A000189313
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LPA1231/52 UltiPace; LPA1231/58 UltiPace; Quadra Allure
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 181 LB