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	Therapy Delivered to Incorrect Body Area (1508); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient exhibited twiddler¿s syndrome causing migration of the pacemaker and dislodgement of the right atrial (ra) and right ventricular (rv) leads.The dislodgement resulted in diaphragmatic stimulation and patient discomfort.Programming changes were made to address the issue.On (b)(6) 2026, during the procedure, the physician explanted the right atrial (ra) lead.A replacement ra lead was installed; however, the lead became dislodged and exhibited noise, high impedance, and low current of injury.Ra lead fracture was suspected.This ra lead was not used, and the physician completed the procedure using a different ra lead replacement.Additionally, the rv lead was explanted and replaced during the procedure.The patient was discharged, same day, following 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: 50952386
• Report Number: 2017865-2026-20766
• Device Sequence Number: 15859087
• Product Code: NVN
• UDI-Device Identifier: 05415067046345
• UDI-Public: (01)05415067046345(10)P000242196(17)280930
• 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): 09/30/2026

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: P000242196
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2025
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female