MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) UltiPace¿ Lead, 52cm MRI; Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Model Number	LPA1231/52
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Therapy Delivered to Incorrect Body Area (1508); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Dizziness (2194)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced dizziness, low blood pressure, and vomiting associated with stimulation of the vagus nerve.Diagnostic imaging was performed and dislodgment of the right atrial (ra) lead was observed.A revision procedure was performed and repositioning of the ra lead was attempted, however, difficulty extending and retracting the helix was noted.The ra lead was explanted and a piece of the ra lead detached outside of the body of the patient.The ra lead was replaced.The patient was in stable condition.

• Brand Name: UltiPace¿ Lead, 52cm 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: 50869722
• Report Number: 2017865-2026-20128
• Device Sequence Number: 10690588
• Product Code: NVN
• UDI-Device Identifier: 05415067046314
• UDI-Public: (01)05415067046314(10)P000259198(17)290531
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: LPA1231/52
• Device Catalogue Number: LPA1231/52
• Device Lot Number: P000259198
• 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: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2026
• 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: Required Intervention
• Patient Sex: Unknown