MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) UltiPace¿ Lead, 46cm MRI; Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Model Number	LPA1231/46
Medical Device Problem Codes	Capturing Problem (2891); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Dyspnea (1816); Cardiac Perforation (2513)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced dyspnea.On, (b)(6) 2026, the physician suspected that the right atrial (ra) had dislodged based on an electrocardiogram (ekg) observation.Device interrogation was performed, and the ra lead exhibited high capture threshold.On (b)(6) 2026, an x-ray was performed, and the ra lead appeared to be in the same location.Programming changes were performed to address the issue.An echocardiogram was performed that same day, and micro perforation of the heart was noted due to the ra lead.The physician explanted the ra lead.The patient was discharged from the hospital after the procedure.
Additional Manufacturer Narrative
Further information was requested but not received.

• Brand Name: UltiPace¿ Lead, 46cm MRI
• Common Device Name: Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
• 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: 50696872
• Report Number: 2017865-2026-19055
• Device Sequence Number: 9614408
• Product Code: NVN
• UDI-Device Identifier: 05415067046345
• UDI-Public: (01)05415067046345(10)P000253537(17)290331
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 09/09/2026

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: LPA1231/46
• Device Catalogue Number: LPA1231/46
• Device Lot Number: P000253537
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2026
• 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: ASSURITY.; ISOFLEX.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 57 YR
• Patient Sex: Female