MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) QUADRA ALLURE MP; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number	PM3542
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for a cardiac resynchronization therapy (crt) implant procedure.During the procedure, after all leads were positioned and secured in the pacemaker header, final fluoroscopy revealed reduced lead slack and dislodgement of the left ventricular (lv) lead.Loss of capture of the lv lead was also noted.The lv lead was subsequently disconnected from the pacemaker and repositioned.While the physician was securing the lv lead into the header, the set screw fell from the pacemaker.As a result, the pacemaker was not used and was replaced.The patient remained stable throughout the procedure.

• Brand Name: QUADRA ALLURE MP
• Common Device Name: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: 25107510
• Report Number: 2017865-2026-09416
• Device Sequence Number: 10249263
• Product Code: NKE
• UDI-Device Identifier: 05414734510080
• UDI-Public: (01)05414734510080(10)P000249555(17)270630
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PM3542
• Device Lot Number: P000249555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/19/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2026
• 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
• Patient Sex: Unknown