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

Model Number	24967
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
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 implantable device replacement procedure loss of blue-tooth between the mobile programmer patient connector and the implantable device was observed with a red 'x' symbol displayed.The issue was encountered when the new device and leads were connected as the user commenced testing the device through the testing menu.The patient connector was then placed in a sterile cover which was then placed on the sterile field over the device however it did not connect with the new device and displayed a diagnostic message stating it was unable to connect and directing the user to turn wireless fidelity (wi-fi) off.The wi-fi was turned off and on followed by force closing and re-starting the mobile programmer application to no avail.The patient connector was then unable to be paired although it still had a solid blue light and various troubleshooting steps advised by technical support failed to resolve the issue.A different patient connector was located to complete the procedure which was significantly delayed.It was noted the customer expressed dissatisfaction with the performance of the product.No patient complications have been reported as a result of this event.
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 loss of blue-tooth between the mobile programmer patient connector and the implantable device was observed was confirmed.Analysis of the service logs found the customer comment that the patient connector was unable to connect to the new device was confirmed.Analysis of the service logs found the customer comment that the patient connector was unable to be paired 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.

• 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: 20585997
• Report Number: 2182208-2024-04673
• Device Sequence Number: 8804644
• Product Code: DSI
• UDI-Device Identifier: 00763000688479
• UDI-Public: 00763000688479
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/11/2024

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: 10/11/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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: 81 YR
• Patient Sex: Male