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

Model Number	2090
Medical Device Problem Codes	Break (1069); Display or Visual Feedback Problem (1184); Component Missing (2306); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the programmer exhibited autonomous cursor movement and failed the finger touch test due to cursor misalignment and jumping.It was also noted that the cord compartment cover was broken and was unable to latch, and that the power cord was missing.There was no patient involvement.
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.
Additional Manufacturer Narrative
Product analysis: analysis was able to confirm the customer comment that the programmer exhibited autonomous cursor movement and failed the finger touch test due to cursor misalignment and jumping.Analysis was also able to confirm the customer comment that the cord compartment cover was broken and was unable to latch, the power cord was missing, the programmer's screen arm was missing the screws and was making noise when lowering the screen.During incoming inspection the programmer failed the touch screen debug procedure and autonomous movement of cursor was observed.It was noted that the hinge plate screws were missing.The upper display hinges were noisy.The power cord bay was broken.The power cord was missing.The rear display cover was cracked.The stylus insulation was breached.The lower display hinges were worn out.The upper handle cover was broken.All found defective parts were replaced and all other identified issues were resolved.The programmer failed the finger touch during final functional test.Electromagnetic interference (emi) repair was performed to resolve the cursor issue.The programmer then passed all final functional and system 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.

• 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: 24106887
• Report Number: 2182208-2026-00547
• Device Sequence Number: 12209852
• Product Code: KRG
• UDI-Device Identifier: 00613994175397
• UDI-Public: (01)00613994175397(11)050815
• 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,Followup
• Report Date (Section B): 03/12/2026

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: Other
• Device Model Number: 2090
• Device Catalogue Number: 2090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2005
• 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