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	Difficult to Fold, Unfold or Collapse (1254); Fitting Problem (2183); Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented to the hospital for a scheduled implant procedure.During the procedure, the left bundle branch area pacing (lbbp) lead helix kept retracting during lead torquing despite using mulitple helix locking tool.Due to the helix mechanism issue, the lbbp lead exhibited inappropriate capture.Additionally, the pacemaker header exhibited a setscrew anomaly.The pacemaker was implanted, however the lbbp lead was removed and replaced.The patient was in a stable condition.
Additional Manufacturer Narrative
Further information was requested but not received.

• 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: 50728338
• Report Number: 2017865-2026-19292
• Device Sequence Number: 10591779
• Product Code: NVN
• UDI-Device Identifier: 05415067046338
• UDI-Public: (01)05415067046338(10)P000258049(17)290531
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/11/2026

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: LPA1231/58
• Device Catalogue Number: LPA1231/58
• Device Lot Number: P000258049
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2026
• 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 Age: 79 YR
• Patient Sex: Female