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 Codes	Failure to Capture (1081); Over-Sensing (1438); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	08/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following a new implant procedure, at the post operative follow up check, it was noted that the left bundle branch pacing (lbbp) exhibited no capture and wide qrs oversensing was observed on the right ventricular (rv) lead.A possible perforation of the rv lead into the left ventricle (lv) was suspected.A ct scan showed the rv lead had migrated/dislodged to the lv myocardium, but it had not penetrated into the lv blood pool.The rv lead was explanted and replaced.The patient was stable.

• 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: 50825390
• Report Number: 2017865-2026-19870
• Device Sequence Number: 16121577
• Product Code: NVN
• UDI-Device Identifier: 05415067046338
• UDI-Public: (01)05415067046338(10)P000253437(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
• Device Explanted 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): 09/18/2026

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: P000253437
• 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: 08/30/2026
• Initial Report FDA Received Date: 09/18/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Assurity MRI; UltiPace RA lead
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown