MAUDE Adverse Event Report: MEDTRONIC, INC. PATIENT CONNECTOR; DETECTOR AND ALARM, ARRHYTHMIA

Model Number	24967
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the end of an implant procedure while manually checking the device connection was lost between the patient connector, mobile application and implantable device.Connection could not be reestablished and the patient connector was changed out for another patient connector.The patient connector has been returned for evaluation.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.Product analysis: analysis was unable to confirm the customer comment that the patient connector lost connection.Final disposition of this unit will be maintained by the contract manufacturer.See analysis attachment.Final disposition of this unit will be maintained by the contract manufacturer.Continuation of d10: product id m01a01; product id w1dr01 serial# (b)(6).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.

• Brand Name: PATIENT CONNECTOR
• Common Device Name: DETECTOR AND ALARM, ARRHYTHMIA
• 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: 21982399
• Report Number: 2182208-2025-02243
• Device Sequence Number: 12840399
• Product Code: DSI
• UDI-Device Identifier: 00763000060428
• UDI-Public: 00763000060428
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 05/08/2025
• Date Device Manufactured: 09/29/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Sex: Unknown