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

Model Number	2090W
Medical Device Problem Codes	Computer Software Problem (1112); Display or Visual Feedback Problem (1184); Problem with Software Installation (3013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: analysis was able to confirm the customer's comment that the programmer generated an error code during a software update.The micro processor unit (mpu) was replaced, and the hard drive was re-imaged.It was noted that the programmer failed the touchscreen debug procedure at final testing.An electromagnetic interference(emi) repair was performed, but the test failed.The xy-printed circuit board (pcb) was replaced to resolve the screen issue.The logo button was missing, the logo button was installed.The upper handle cover was damaged.The handle cover was replaced.The programmer then passed all final functional and systems tests.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the programmer generated an error code during a software update.Troubleshooting steps were taken to reboot the device twice.The programmer has been returned for evaluation and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

• Brand Name: CARELINK 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: 22082051
• Report Number: 2182208-2025-02534
• Device Sequence Number: 17879528
• Product Code: KRG
• UDI-Device Identifier: 00885074301440
• UDI-Public: 00885074301440
• 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): 05/24/2025

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: Other
• Device Model Number: 2090W
• Device Catalogue Number: 2090W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 05/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2006
• 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