MAUDE Adverse Event Report: St. Jude Medical Operations (M) SDN BHD UltiPace¿ Lead, 52cm MRI; Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Model Number	LPA1231/52
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2026
Type of Reportable Event	Malfunction

• Brand Name: UltiPace¿ Lead, 52cm MRI
• Common Device Name: Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
• Manufacturer (Section D): St. Jude Medical Operations (M) SDN BHD; plot 102, lebuhraya kampung jawa; bayan lepas industrial zone; penang, pulau pinang 11900 ; MY 11900
• Manufacturer (Section G): St. Jude Medical Operations (M) SDN BHD; plot 102, lebuhraya kampung jawa; bayan lepas industrial zone; penang, pulau pinang 11900 ; MY 11900
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50928519
• Report Number: 3008377825-2026-00006
• Device Sequence Number: 21514074
• Product Code: NVN
• UDI-Device Identifier: 05415067046314
• UDI-Public: (01)05415067046314(10)P000256298(17)290430
• 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): 09/29/2026

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: LPA1231/52
• Device Catalogue Number: LPA1231/52
• Device Lot Number: P000256298
• 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: 09/16/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2026
• 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 Sex: Unknown