MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK ENCORE PROGRAMMER; PROGRAMMER, PACEMAKER

Model Number	29901A
Medical Device Problem Codes	Computer Software Problem (1112); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
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 the user reported difficulty using the programmer during a device follow-up session.The user selected the appropriate device model and initiated interrogation, which was successfully completed.However, the programmer displayed a persistent message at the top of the screen stating, ¿serious software problem.¿ an additional pop-up message appeared stating, ¿quick look follow up generating complete report,¿ at which point the system froze.The programmer subsequently resumed normal function after a period of time.It was noted a separate message was displayed indicating, ¿inconsistent date and time settings have been detected on the programmer.It was confirmed programmer date and time were accurate.Troubleshooting steps were taken to check the software version.No patient complications have been reported as a result of this event.

• Brand Name: CARELINK ENCORE PROGRAMMER
• Common Device Name: PROGRAMMER, PACEMAKER
• 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: 25066106
• Report Number: 2182208-2026-25748
• Device Sequence Number: 9778704
• Product Code: KRG
• UDI-Device Identifier: 00643169763548
• UDI-Public: (01)00643169763548(11)200320
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: 29901A
• Device Catalogue Number: 29901A
• 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: 04/06/2026
• Initial Report FDA Received Date: 05/04/2026
• Date Device Manufactured: 03/20/2020
• 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: 82 YR
• Patient Sex: Male