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	Failure to Capture (1081); Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented to the clinic for a scheduled follow-up visit.Interrogation revealed loss of sensing and loss of capture of the right atrial (ra) lead, as well as loss of capture of the left ventricular (lv) lead.A chest x-ray confirmed dislodgement of both the ra and lv leads.A planned dual-lead revision procedure was scheduled via a right-sided approach due to left subclavian vein occlusion.During the procedure, the lv lead could not be explanted because of extensive fibrotic tissue encasing the lead body.Consequently, the physician elected to explant the ra lead and reposition the chronic lv lead into the right atrium to provide atrial sensing and trigger right ventricular pacing.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: 50316272
• Report Number: 2017865-2026-17412
• Device Sequence Number: 13160804
• Product Code: NIK
• UDI-Device Identifier: 05414734510219
• UDI-Public: (01)05414734510219(10)A000152890(17)261231
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/19/2026

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: A000152890
• 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: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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: Quadra Allure.; Tendril.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female