MAUDE Adverse Event Report: Medtronic, Inc. Programming Head; PROGRAMMER, PACEMAKER

Model Number	2067L
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The radiofrequency (rf) head was returned for evaluation as an associated device and subsequently tested out of specification during the manufacturer's analysis.There was no patient involvement.
Additional Manufacturer Narrative
Product analysis: it was determined at analysis that the radiofrequency (rf) was not working correctly.During visual inspection, it was observed that there was a cut in the rf-head cable and the overall shielding was visible.When the rf-head was plugged in, the programmer shut down.The programmer also didn't turn on with the rf-head plugged in.When the rf-head was unplugged, the programmer started and booted up normally.It was noted that the damaged and cut cable caused a short circuit, which prevented the programmer from starting up.The rf-head cable was replaced, and the cable and plug were checked, and then a cable stretch test was performed.The rf-head worked correctly.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: Programming Head
• 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--439 ; +1(763)526-9277
• MDR Report Key: 50219815
• Report Number: 2182208-2026-48939
• Device Sequence Number: 18786182
• Product Code: KRG
• UDI-Device Identifier: 00613994435125
• UDI-Public: (01)00613994435125(11)110531
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: Health Professional
• Device Model Number: 2067L
• Device Catalogue Number: 2067L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2090 PROGRAMMER
• Patient Sex: Unknown