MAUDE Adverse Event Report: MEDTRONIC, INC. PATIENT CONNECTOR; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number	24967
Medical Device Problem Codes	Computer Software Problem (1112); Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896); Computer Operating System Problem (2898); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a ventricular threshold test, the connection between the patient connector and the implantable device was interrupted, resulting in a warning message indicating the loss of connection.After selecting ok, an hourglass icon appeared on the screen.Troubleshooting steps were taken to include minimizing the mobile programmer application, navigating to the home screen, and reopening the application.Upon reopening, the screen appeared completely white.The same process was repeated, after which the electrograms (egm) from the device was visible again, but all operational buttons were grayed out and unresponsive.The mobile prog rammer application was force closed, and the device was reinterrogated after the surgical incision was closed.No patient complications have been reported as a result of this event.Application version: 5.3.2 host tablet os version: 18.5.
Additional Manufacturer Narrative
Product analysis: performance data collected from the mobile programmer was received and analyzed.Analysis of the service logs found the customer comment that the connection between the patient connector and the implantable device was interrupted, resulting in a warning message indicating the loss of connection was confirmed.Analysis of the service logs found the customer comment that an hourglass icon appeared on the screen was confirmed.Analysis of the service logs found the customer comment that the screen appeared completely white could not be confirmed.Analysis of the service logs found the customer comment that all operational buttons were grayed out and unresponsive was confirmed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Application version: 4.4.2 host tablet os version: 18.5.

• Brand Name: PATIENT CONNECTOR
• Common Device Name: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 23413566
• Report Number: 2182208-2025-07473
• Device Sequence Number: 8956637
• Product Code: OSR
• UDI-Device Identifier: 00763000060428
• UDI-Public: (01)00763000060428(11)200615
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 24967
• Device Catalogue Number: 24967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 86 KG