Pacing System Analyzer
Received Jul 30, 2026 · Event occurred Jul 29, 2026
Report 2182208-2026-46858 · MDR key 50080022
Device
Product problems
- Connection Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the analyzer's lower middle pin got jammed and it was noted that the lead was unable to insert fully. No patient complications have been reported as a result of this event.
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.