MAUDE Adverse Event Report: Medtronic, Inc. Patient Connector; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number	24967
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896); Problem with Software Installation (3013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blue portion of the patient connector used to hang around the patient's neck was damaged and required replacement.It was noted that the replacement connector displayed a security certificate expired message.It was further noted that the replacement connector could not be paired with the mobile programmer application due to bluetooth connectivity issues.Troubleshooting steps were taken to include removing the bluetooth pairing, rebooting the host tablet, and pairing the connector as a new device.It was further noted that a connector update needed message was displayed; however, the update failed despite multiple attempts. performance data collected from the mobile programmer was received and analyzed.Analysis determined that bluetooth connection was lost.There was no patient involvement.
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 replacement connector displayed a security certificate expired message and that the replacement connector could not be paired with the mobile programmer application due to bluetooth connectivity issues was confirmed.Analysis determined that bluetooth connection was lost.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: 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--439 ; +1(763)526-9277
• MDR Report Key: 50732356
• Report Number: 2182208-2026-51802
• Device Sequence Number: 18789577
• Product Code: OSR
• UDI-Device Identifier: 00763000060428
• UDI-Public: (01)00763000060428(11)200825
• 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): 09/11/2026

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: 24967
• Device Catalogue Number: 24967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2020
• 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 Sex: Unknown