MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) VICTORY XL DR; Implantable Pacemaker Pulse-Generator

Model Number	5816
Medical Device Problem Code	Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for a follow-up in clinic.Interrogation revealed that the pacemaker had entered backup vvi mode.The patient was then admitted to the hospital and attempts to restore the pacemaker to normal operation through reprogramming were unsuccessful due to normal battery depletion.No intervention or changes were performed.No patient consequences were reported.
Additional Manufacturer Narrative
The reported implant date is an estimate.The implant date was reported as follow, ¿the pacemaker was implanted in 2018, but the exact date is unknown¿.

• Brand Name: VICTORY XL DR
• Common Device Name: Implantable Pacemaker Pulse-Generator
• 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: 50465139
• Report Number: 2017865-2026-18003
• Device Sequence Number: 10175875
• Product Code: DXY
• UDI-Device Identifier: 05414734009553
• UDI-Public: (01)05414734009553(10)P000058394(17)190930
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 08/27/2026

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 Expiration Date: 09/30/2019
• Device Model Number: 5816
• Device Lot Number: P000058394
• 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: 08/07/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2018
• 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: Hospitalization
• Patient Sex: Unknown