MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) UltiPace¿ Lead, 58cm MRI; Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Model Number	LPA1231/58
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	07/26/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient presented for an initial implant of a pacemaker (pm) system post heart surgery (bentall procedure).It was noted that the patient had a temporary pacing wire already inserted.The pm system was implanted successfully, and the temporary pacing wire was left insitu but inactivated.An hour post-procedure, the patient went into asystole, and cardiopulmonary resuscitation (cpr) was initiated, turning on the pacing wire; however, it was not capturing.The pm was interrogated, which showed no capture and an elevated pacing impedance.The patient subsequently passed.There are no allegations that the death is related to the pm system, and that the patient experienced an ischemic episode post-cardiac surgery.

• Brand Name: UltiPace¿ Lead, 58cm 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: 50742670
• Report Number: 2017865-2026-19331
• Device Sequence Number: 10159641
• Product Code: NVN
• UDI-Device Identifier: 05415067046338
• UDI-Public: (01)05415067046338(10)P000253402(17)290331
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: LPA1231/58
• Device Catalogue Number: LPA1231/58
• Device Lot Number: P000253402
• 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: 08/13/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2026
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown