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

Model Number	2090W
Medical Device Problem Codes	Computer Software Problem (1112); No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: analysis was unable to confirm the customer's comment that the programmer displayed a black screen that displayed a diagnostic message saying, "serious programmer error".However, a system error was recorded in the recent error log.The hard drive was reimaged.It was noted that the programmer failed the touch screen debug procedure, and autonomous movement of the cursor was observed.An electromagnetic interference(emi) repair was performed to correct the screen issue.Additionally, it was noted that the power cord bay was broken.Replaced the power cord bay assembly with one tab.The q button was missing from the keyboard.The keyboard was replaced.The logo button was missing.The logo button was installed.The system fan wire was broken.The system fan was replaced.The software was reloaded and updated.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.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 programmer displayed a black screen that displayed a diagnostic message saying "serious programmer error".Troubleshooting steps were taken to power cycle the programmer after which it cleared the black screen.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: 21958795
• Report Number: 2182208-2025-02185
• Device Sequence Number: 21131660
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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: 02/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/05/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2182208-071724-002-R
• Patient Sequence Number: 1
• Patient Sex: Unknown